Shawahna, Ramzi; Al-Rjoub, Mohammed; Al-Horoub, Mohammed M; Al-Hroub, Wasif; Al-Rjoub, Bisan; Al-Nabi, Bashaaer Abd
2016-01-01
This study aimed to investigate community pharmacists' knowledge and certainty of adverse effects and contraindications of pharmaceutical products to estimate the risk of error. Factors influencing their knowledge and certainty were also investigated. The knowledge of community pharmacists was assessed in a cross-sectional design using a multiple-choice questions test on the adverse effects and contraindications of active pharmaceutical ingredients and excipients from May 2014 to March 2015. Self-rated certainty scores were also recorded for each question. Knowledge and certainty scores were combined to estimate the risk of error. Out of 315 subjects, 129 community pharmacists (41.0%) completed the 30 multiple-choice questions test on active ingredients and excipients. Knowledge on active ingredients was associated with the year of graduation and obtaining a licence to practice pharmacy. Knowledge on excipients was associated with the degree obtained. There was higher risk of error in items on excipients than those on ingredients (P<0.01). The knowledge of community pharmacists in Palestine was insufficient with high risk of errors. Knowledge of community pharmacists on the safety issues of active ingredients and excipients need to be improved.
USDA-ARS?s Scientific Manuscript database
The impact of different spray tank modifiers into an active ingredient spray mixture on spray atomization and in-field behavior under aerial application conditions were examined. Wind tunnel tests demonstrated that active ingredient solutions potentially results in significantly different atomizati...
Schmidts, T; Dobler, D; Schlupp, P; Nissing, C; Garn, H; Runkel, F
2010-10-15
Multiple water-in-oil-in-water (W/O/W) emulsions are of major interest as potential skin delivery systems for water-soluble drugs like oligonucleotides due to their distinct encapsulation properties. However, multiple emulsions are highly sensitive in terms of variations of the individual components. The presence of osmotic active ingredients in the inner water phase is crucial for the generation of stable multiple emulsions. In order to stabilize the emulsions the influence of NaCl, MgSO(4), glucose and glycine and two cellulose derivatives was investigated. Briefly, multiple W/O/W emulsions using Span 80 as a lipophilic emulsifier and different hydrophilic emulsifiers (PEG-40/50 stearate, steareth-20 and polysorbate 80) were prepared. Stability of the emulsions was analyzed over a period of time using rheological measurements, droplet size observations and conductivity analysis. In this study we show that additives strongly influence the properties stability of multiple emulsions. By increasing the concentration of the osmotic active ingredients, smaller multiple droplets are formed and the viscosity is significantly increased. The thickening agents resulted in a slightly improved stability. The most promising emulsions were chosen and further evaluated for their suitability and compatibility to incorporate a DNAzyme oligonucleotide as active pharmaceutical ingredient. Copyright 2010 Elsevier B.V. All rights reserved.
Wardrop, J; Jaber, A B; Ayres, J W
1998-08-01
The purpose of this study was to produce novel multiple-layer, compression-coated, chewable tablet formulations containing amoxicillin trihydrate, and clavulanic acid as potassium clavulanate, and to test in vitro dissolution characteristics and the effect of humidity stability compared to Augmentin chewable tablets as a reference. Double- and triple-layer tablets were manufactured on a laboratory scale by multiple-layer dry compression, and dissolution profiles of both active ingredients were determined. Tablets were subjected to stability evaluation in laboratory-scale humidity tanks maintained at constant humidity. Assay of content was determined by HPLC or UV spectroscopy. Physical characteristics of the powder mixture, such as angle of repose, and of tablets for hardness and friability, were also determined. Chewable tablets showed similar dissolution profiles in vitro for both active ingredients, compared to the marketed reference, Augmentin. The stability of clavulanic acid, but not amoxicillin, was increased in the novel triple or bilayer formulation. The tablets showed suitable friability, hardness, and angle of repose for starting materials to suggest that industrial scale-up is feasible. This approach to formulation of drugs containing multiple or moisture-sensitive ingredients has been shown to increase the stability of the central core drug without changing the dissolution pattern of the active ingredients. This formulation is expected to be bioequivalent in vivo based on these in vitro results.
Wu, Jia-sheng; Shi, Rong; Zhong, Jie; Lu, Xiong; Ma, Bing-liang; Wang, Tian-ming; Zan, Bin; Ma, Yue-ming; Cheng, Neng-neng; Qiu, Fu-rong
2013-01-01
In Chinese medicine, Xiexin decoction (XXD) has been used for the clinical treatment of diabetes for at least 1700 years. The present study was conducted to investigate the effective ingredients of XXD and their molecular mechanisms of antidiabetic nephropathy in rats. Rats with diabetes induced by high-fat diet and streptozotocin were treated with XXD extract for 12 weeks. XXD significantly improved the glucolipid metabolism disorder, attenuated albuminuria and renal pathological changes, reduced renal advanced glycation end-products, inhibited receptor for advanced glycation end-product and inflammation factors expression, suppressed renal nuclear factor-κB pathway activity, and downregulated renal transforming growth factor-β1. The concentrations of multiple components in plasma from XXD were determined by liquid chromatography and tandem mass spectrometry. Pharmacokinetic/pharmacodynamic analysis using partial least square regression revealed that 8 ingredients of XXD were responsible for renal protective effects via actions on multiple molecular targets. Our study suggests that the renal protective role of XXD with multiple effective ingredients involves inhibition of inflammation through downregulation of the nuclear factor-κB pathway, reducing renal advanced glycation end-products and receptor for advanced glycation end-product in diabetic rats. PMID:23935673
Booth, Ewan D; Rawlinson, Paul J; Maria Fagundes, Priscila; Leiner, Kevin A
2017-06-01
Active ingredients in plant protection products are subject to rigorous safety assessment during their development, including assessment of genotoxicity. Plant protection products are used for agriculture in multiple regions and for the registration of active ingredients it is necessary to satisfy the data requirements of these different regions. There are no overarching global agreements on which genotoxicity studies need to be conducted to satisfy the majority of regulatory authorities. The implementation of new OECD guidelines for the in vitro micronucleus, transgenic rodent somatic and germ cell gene mutation and in vivo comet assays, as well as the revision of a number of other OECD test guidelines has resulted in some changes to data requirements. This review describes the genotoxicity data requirements for chemical active ingredients as well as biologicals, microbials, ground water metabolites, metabolites, and impurities in a number of regions. Similarities and differences are highlighted. Environ. Mol. Mutagen. 58:325-344, 2017. © 2017 Wiley Periodicals, Inc. © 2017 Wiley Periodicals, Inc.
The formulation makes the honey bee poison.
Mullin, Christopher A; Chen, Jing; Fine, Julia D; Frazier, Maryann T; Frazier, James L
2015-05-01
Dr. Fumio Matsumura's legacy embraced a passion for exploring environmental impacts of agrochemicals on non-target species such as bees. Why most formulations are more toxic to bees than respective active ingredients and how pesticides interact to cause pollinator decline cannot be answered without understanding the prevailing environmental chemical background to which bees are exposed. Modern pesticide formulations and seed treatments, particularly when multiple active ingredients are blended, require proprietary adjuvants and inert ingredients to achieve high efficacy for targeted pests. Although we have found over 130 different pesticides and metabolites in beehive samples, no individual pesticide or amount correlates with recent bee declines. Recently we have shown that honey bees are sensitive to organosilicone surfactants, nonylphenol polyethoxylates and the solvent N-methyl-2-pyrrolidone (NMP), widespread co-formulants used in agrochemicals and frequent pollutants within the beehive. Effects include learning impairment for adult bees and chronic toxicity in larval feeding bioassays. Multi-billion pounds of formulation ingredients like NMP are used and released into US environments. These synthetic organic chemicals are generally recognized as safe, have no mandated tolerances, and residues remain largely unmonitored. In contrast to finding about 70% of the pesticide active ingredients searched for in our pesticide analysis of beehive samples, we have found 100% of the other formulation ingredients targeted for analysis. These 'inerts' overwhelm the chemical burden from active pesticide, drug and personal care ingredients with which they are formulated. Honey bees serve as an optimal terrestrial bioindicator to determine if 'the formulation and not just the dose makes the poison'. Copyright © 2014 Elsevier Inc. All rights reserved.
Drugs and Diseases Interacting with Cigarette Smoking in US Prescription Drug Labelling.
Li, Haibo; Shi, Qiang
2015-05-01
The US Food and Drug Administration (FDA) draft guidance for industry on drug interaction studies recommends, but does not mandate, that both cigarette smokers and non-smokers can be used to study drug metabolism in clinical trials, and that important results related to smoking should be included in drug labelling to guide medication usage. This study aimed to provide a comprehensive review of drugs or diseases interacting with smoking, as presented in all US drug labelling. The 62,857 drug labels deposited in the FDA Online Label Repository were searched using the keywords 'smoke', 'smoker(s)', 'smoking', 'tobacco' and 'cigarette(s)' on 19 June 2014. The resultant records were refined to include only human prescription drug labelling, for manual examination. For 188 single-active-ingredient drugs and 36 multiple-active-ingredient drugs, the labelling was found to contain smoking-related information. The pharmacokinetics of 29 and 21 single-active-ingredient drugs were affected and unaffected, respectively, by smoking. For the remaining drugs, the provided information related to smoking affecting efficacy, safety or diseases but not pharmacokinetics. Depending on the nature of specific drugs, the perturbation in pharmacokinetic parameters in smokers ranged from 13 to 500%, in comparison with non-smokers. Dosage modifications in smokers are necessary for four drugs and may be necessary for six drugs, but are unnecessary for seven drugs although the pharmacokinetic parameters of four of them are affected by smoking. Cigarette smoking is a risk factor for 16 types of diseases or adverse drug reactions. For one single-active-ingredient contraceptive drug and 10 multiple-active-ingredient contraceptive drugs, a black box warning (the FDA's strongest safety warning) is included in the labelling for increased risks of heart attacks and strokes in female smokers, and "women are strongly advised not to smoke" when using these drugs. This study presents the first comprehensive overview of cigarette smoking interacting with drugs and/or diseases, as presented in US drug labelling.
Okamoto, Hitoshi; Nakajima, Toshiaki; Ito, Yuji; Aketo, Takao; Shimada, Kenji; Yamato, Susumu
2005-03-09
Cyclodextrin-modified microemulsion electrokinetic chromatography (CD-MEEKC) was used to simultaneously determine 14 active ingredients (thiamine nitrate, anhydrous caffeine, acetaminophen, riboflavin, guaifenesin, pseudoephedrine hydrochloride, ascorbic acid, ethenzamide, DL-methylephedrine hydrochloride, dihydrocodeine phosphate, ibuprofen, noscapine, carbinoxamine maleate, and bromhexine hydrochloride) in a cold medicine. Separation of the ingredients was optimized by changing the SDS concentration and oil type and the addition of 2-propanol and cyclodextrin (CD) to the separation solution. The separation selectivity was improved dramatically by changing CD type. All of the active ingredients and formulation excipients were successfully separated with the use of a separation solution consisting of 0.81% (w/w) pentane, 6.61% (w/w) 1-butanol, 2% (w/w) 2-propanol, 4.47% (w/w) SDS, and 86.11% (w/w) 10 mM sodium tetraborate solution with 3 mM 2,6-di-O-methyl-beta-CD. The established method was then validated and demonstrated to be applicable to the determination of the active ingredients in a model cold medicine. No interference from the formulation excipients was observed. Good linearities were obtained with correlation coefficients above 0.999. Recovery and precision ranged from 99.1 to 100.7% and from 0.5 to 2.8% R.S.D., respectively. The detection limit for ingredients ranged from 0.6 to 4.2 microg ml(-1). Good agreement was obtained between the established method and the traditional HPLC method. These results suggest that CD-MEEKC can be used for the determination of multiple ingredients in cold medicine.
Stringer, Barbara; van Meijel, Berno; Karman, Pieter; Koekkoek, Bauke; Hoogendoorn, Adriaan W; Kerkhof, Ad J F M; Beekman, Aartjan T F
2015-07-01
To test if a collaborative care program (CCP) with nurses in a coordinating position is beneficial for patients with severe personality disorders. A pilot study with a comparative multiple case study design using mixed methods investigating active ingredients and preliminary results. Most patients, their informal caregivers, and nurses value (parts of) the CCP positively; preliminary results show a significant decrease in severity of borderline symptoms. With the CCP, we may expand the supply of available treatments for patients with (severe) personality disorders, but a larger randomized controlled trial is warranted to confirm our preliminary results. © 2014 Wiley Periodicals, Inc.
Guha, Neela; Ward, Mary H.; Gunier, Robert; Colt, Joanne S.; Lea, C. Suzanne; Buffler, Patricia A.
2012-01-01
Background: Home and garden pesticide use has been linked to cancer and other health outcomes in numerous epidemiological studies. Exposure has generally been self-reported, so the assessment is potentially limited by recall bias and lack of information on specific chemicals. Objectives: As part of an integrated assessment of residential pesticide exposure, we identified active ingredients and described patterns of storage and use. Methods: During a home interview of 500 residentially stable households enrolled in the Northern California Childhood Leukemia Study during 2001–2006, trained interviewers inventoried residential pesticide products and queried participants about their storage and use. U.S. Environmental Protection Agency registration numbers, recorded from pesticide product labels, and pesticide chemical codes were matched to public databases to obtain information on active ingredients and chemical class. Poisson regression was used to identify independent predictors of pesticide storage. Analyses were restricted to 259 participating control households. Results: Ninety-five percent (246 of 259) of the control households stored at least one pesticide product (median, 4). Indicators of higher sociodemographic status predicted more products in storage. We identified the most common characteristics: storage areas (garage, 40%; kitchen, 20%), pests treated (ants, 33%; weeds, 20%), pesticide types (insecticides, 46%; herbicides, 24%), chemical classes (pyrethroids, 77%; botanicals, 50%), active ingredients (pyrethrins, 43%) and synergists (piperonyl butoxide, 42%). Products could contain multiple active ingredients. Conclusions: Our data on specific active ingredients and patterns of storage and use will inform future etiologic analyses of residential pesticide exposures from self-reported data, particularly among households with young children. PMID:23110983
Choleretic Activity of Turmeric and its Active Ingredients.
Wang, Yonglu; Wang, Liyao; Zhu, Xinyi; Wang, Dong; Li, Xueming
2016-07-01
Turmeric, a rhizome of Curcumin longa L. is widely used as both a spice and an herbal medicine. The traditional use of turmeric in gastroenterology is mainly based on its choleretic activity. The aim of this study is to determine the effects of turmeric on bile flow (BF) and total bile acids (TBAs) excretion in a bile fistula rat model after acute duodenal administration. A significant dose-dependent enhancement in both BF and TBAs was detected after treatment with the turmeric decoctions which suggested the choleretic activity was bile acid-dependent secretion. In order to direct the active group of compounds, aqueous (AE), ethyl acetate (EtOAc), and petroleum ether (PE) extracts were investigated. The EtOAc and PE extracts showing high effects were purified to locate the active ingredients. Three curcuminoids (curcumin, demethoxycurcumin, and bisdemethoxycurcumin) and 2 sesquiterpenes (bisacurone B and ar-turmerone) were isolated. It was found Bisacurone B was the most potent choleretic ingredient followed by ar-turmerone, bisdemethoxycurcumin demethoxycurcumin, and then curcumin. The amounts of the active ingredients were quantitatively analyzed by high-performance liquid chromatography. The EtOAc and PE extracts had high sesquiterpenes and curcuminoids content, while the AE extract had poor content of sesquiterpenes and curcuminoids which affected neither BF nor TBAs. Based on the results of multiple linear regression analysis, the content of BIS and TUR were dominant factors (P < 0.01) of controlling BL and TBAs in EtOAC and PE extracts. © 2016 Institute of Food Technologists®
21 CFR 352.20 - Permitted combinations of active ingredients.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Permitted combinations of active ingredients. 352... INDEFINITELY] Active Ingredients § 352.20 Permitted combinations of active ingredients. The SPF of any...) Combinations of sunscreen active ingredients. (1) Two or more sunscreen active ingredients identified in § 352...
21 CFR 352.20 - Permitted combinations of active ingredients.
Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Permitted combinations of active ingredients. 352... INDEFINITELY] Active Ingredients § 352.20 Permitted combinations of active ingredients. The SPF of any...) Combinations of sunscreen active ingredients. (1) Two or more sunscreen active ingredients identified in § 352...
21 CFR 352.20 - Permitted combinations of active ingredients.
Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Permitted combinations of active ingredients. 352... INDEFINITELY] Active Ingredients § 352.20 Permitted combinations of active ingredients. The SPF of any...) Combinations of sunscreen active ingredients. (1) Two or more sunscreen active ingredients identified in § 352...
21 CFR 352.20 - Permitted combinations of active ingredients.
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Permitted combinations of active ingredients. 352... INDEFINITELY] Active Ingredients § 352.20 Permitted combinations of active ingredients. The SPF of any...) Combinations of sunscreen active ingredients. (1) Two or more sunscreen active ingredients identified in § 352...
21 CFR 352.20 - Permitted combinations of active ingredients.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Permitted combinations of active ingredients. 352... INDEFINITELY] Active Ingredients § 352.20 Permitted combinations of active ingredients. The SPF of any...) Combinations of sunscreen active ingredients. (1) Two or more sunscreen active ingredients identified in § 352...
Chen, X; Zhou, H; Liu, Y B; Wang, J F; Li, H; Ung, C Y; Han, L Y; Cao, Z W; Chen, Y Z
2006-12-01
Traditional Chinese Medicine (TCM) is widely practised and is viewed as an attractive alternative to conventional medicine. Quantitative information about TCM prescriptions, constituent herbs and herbal ingredients is necessary for studying and exploring TCM. We manually collected information on TCM in books and other printed sources in Medline. The Traditional Chinese Medicine Information Database TCM-ID, at http://tcm.cz3.nus.edu.sg/group/tcm-id/tcmid.asp, was introduced for providing comprehensive information about all aspects of TCM including prescriptions, constituent herbs, herbal ingredients, molecular structure and functional properties of active ingredients, therapeutic and side effects, clinical indication and application and related matters. TCM-ID currently contains information for 1,588 prescriptions, 1,313 herbs, 5,669 herbal ingredients, and the 3D structure of 3,725 herbal ingredients. The value of the data in TCM-ID was illustrated by using some of the data for an in-silico study of molecular mechanism of the therapeutic effects of herbal ingredients and for developing a computer program to validate TCM multi-herb preparations. The development of systems biology has led to a new design principle for therapeutic intervention strategy, the concept of 'magic shrapnel' (rather than the 'magic bullet'), involving many drugs against multiple targets, administered in a single treatment. TCM offers an extensive source of examples of this concept in which several active ingredients in one prescription are aimed at numerous targets and work together to provide therapeutic benefit. The database and its mining applications described here represent early efforts toward exploring TCM for new theories in drug discovery.
Reid, Allecia E.; Carey, Kate B.
2015-01-01
Interventions to reduce college student drinking, although efficacious, generally yield only small effects on behavior change. Examining mechanisms of change may help to improve the magnitude of intervention effects by identifying effective and ineffective active ingredients. Informed by guidelines for establishing mechanisms of change, we conducted a systematic review of alcohol interventions for college students to identify (a) which constructs have been examined and received support as mediators, (b) circumstances that enhance the likelihood of detecting mediation, and (c) the extent of evidence for mechanisms of change. We identified 61 trials that examined 22 potential mediators of intervention efficacy. Descriptive norms consistently mediated normative feedback interventions. Motivation to change consistently failed to mediate motivational interviewing interventions. Multiple active ingredient interventions were not substantially more likely to find evidence of mediation than single ingredient interventions. Delivering intervention content remotely reduced likelihood of finding support for mediation. With the exception of descriptive norms, there is inadequate evidence for the psychosocial constructs purported as mechanisms of change in the college drinking literature. Evidence for mechanisms will be yielded by future studies that map all active ingredients to targeted psychosocial outcomes and that assess potential mediators early, inclusively, and at appropriate intervals following interventions. PMID:26164065
21 CFR 347.20 - Permitted combinations of active ingredients.
Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Permitted combinations of active ingredients. 347... Active Ingredients § 347.20 Permitted combinations of active ingredients. (a) Combinations of skin protectant active ingredients. (1) Any two or more of the ingredients identified in § 347.10(a), (d), (e), (i...
21 CFR 347.20 - Permitted combinations of active ingredients.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Permitted combinations of active ingredients. 347... Active Ingredients § 347.20 Permitted combinations of active ingredients. (a) Combinations of skin protectant active ingredients. (1) Any two or more of the ingredients identified in § 347.10(a), (d), (e), (i...
21 CFR 347.20 - Permitted combinations of active ingredients.
Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Permitted combinations of active ingredients. 347... Active Ingredients § 347.20 Permitted combinations of active ingredients. (a) Combinations of skin protectant active ingredients. (1) Any two or more of the ingredients identified in § 347.10(a), (d), (e), (i...
21 CFR 347.20 - Permitted combinations of active ingredients.
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Permitted combinations of active ingredients. 347... Active Ingredients § 347.20 Permitted combinations of active ingredients. (a) Combinations of skin protectant active ingredients. (1) Any two or more of the ingredients identified in § 347.10(a), (d), (e), (i...
Potter, David J
2014-01-01
The quality demands of the pharmaceutical industry require prescription medicines to be consistent in their active ingredient content. Achieving this, using raw cannabis as a feedstock, is especially challenging. The plant material is extremely inhomogeneous, and the ratios of active ingredients are affected by a range of factors. These include the genetics of the plant, the growing and storage conditions, the state of maturity at harvest, and the methods used to process and formulate the material. The reasons for this variability are described, with particular emphasis on the botanical considerations. To produce the complex botanical medicine Sativex®, which contains the cannabinoids Δ(9)-tetrahydrocannabinol (THC) and cannabidiol (CBD) and a range of other ingredients, GW Pharmaceuticals had to manage these variables. This medicine, for the treatment of spasticity due to multiple sclerosis, is the first cannabis-based medicine to be approved in the UK. The company's methodology for producing this and other chemotypes is described. Copyright © 2013 John Wiley & Sons, Ltd.
21 CFR 346.14 - Protectant active ingredients.
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Protectant active ingredients. 346.14 Section 346...) DRUGS FOR HUMAN USE ANORECTAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 346.14 Protectant active ingredients. (a) The following active ingredients may be used as the sole protectant active...
21 CFR 346.14 - Protectant active ingredients.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Protectant active ingredients. 346.14 Section 346...) DRUGS FOR HUMAN USE ANORECTAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 346.14 Protectant active ingredients. (a) The following active ingredients may be used as the sole protectant active...
21 CFR 346.14 - Protectant active ingredients.
Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Protectant active ingredients. 346.14 Section 346...) DRUGS FOR HUMAN USE ANORECTAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 346.14 Protectant active ingredients. (a) The following active ingredients may be used as the sole protectant active...
21 CFR 346.14 - Protectant active ingredients.
Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Protectant active ingredients. 346.14 Section 346...) DRUGS FOR HUMAN USE ANORECTAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 346.14 Protectant active ingredients. (a) The following active ingredients may be used as the sole protectant active...
21 CFR 341.18 - Expectorant active ingredient.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Expectorant active ingredient. 341.18 Section 341.18 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED...-COUNTER HUMAN USE Active Ingredients § 341.18 Expectorant active ingredient. The active ingredient of the...
21 CFR 335.10 - Antidiarrheal active ingredients.
Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Antidiarrheal active ingredients. 335.10 Section...) DRUGS FOR HUMAN USE ANTIDIARRHEAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 335.10 Antidiarrheal active ingredients. The active ingredient of the product consists of any one of the...
21 CFR 341.20 - Nasal decongestant active ingredients.
Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Nasal decongestant active ingredients. 341.20... OVER-THE-COUNTER HUMAN USE Active Ingredients § 341.20 Nasal decongestant active ingredients. The active ingredient of the product consists of any of the following when used within the dosage limits and...
21 CFR 335.10 - Antidiarrheal active ingredients.
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Antidiarrheal active ingredients. 335.10 Section...) DRUGS FOR HUMAN USE ANTIDIARRHEAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 335.10 Antidiarrheal active ingredients. The active ingredient of the product consists of any one of the...
21 CFR 341.18 - Expectorant active ingredient.
Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Expectorant active ingredient. 341.18 Section 341.18 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED...-COUNTER HUMAN USE Active Ingredients § 341.18 Expectorant active ingredient. The active ingredient of the...
21 CFR 331.11 - Listing of specific active ingredients.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Listing of specific active ingredients. 331.11... (CONTINUED) DRUGS FOR HUMAN USE ANTACID PRODUCTS FOR OVER-THE-COUNTER (OTC) HUMAN USE Active Ingredients § 331.11 Listing of specific active ingredients. (a) Aluminum-containing active ingredients: (1) Basic...
21 CFR 341.14 - Antitussive active ingredients.
Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Antitussive active ingredients. 341.14 Section 341.14 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED...-COUNTER HUMAN USE Active Ingredients § 341.14 Antitussive active ingredients. The active ingredients of...
21 CFR 341.20 - Nasal decongestant active ingredients.
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Nasal decongestant active ingredients. 341.20... OVER-THE-COUNTER HUMAN USE Active Ingredients § 341.20 Nasal decongestant active ingredients. The active ingredient of the product consists of any of the following when used within the dosage limits and...
21 CFR 346.12 - Vasoconstrictor active ingredients.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Vasoconstrictor active ingredients. 346.12 Section...) DRUGS FOR HUMAN USE ANORECTAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 346.12 Vasoconstrictor active ingredients. The active ingredient of the product consists of any of the following when...
21 CFR 341.12 - Antihistamine active ingredients.
Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Antihistamine active ingredients. 341.12 Section 341.12 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED...-COUNTER HUMAN USE Active Ingredients § 341.12 Antihistamine active ingredients. The active ingredient of...
21 CFR 341.16 - Bronchodilator active ingredients.
Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Bronchodilator active ingredients. 341.16 Section 341.16 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED...-COUNTER HUMAN USE Active Ingredients § 341.16 Bronchodilator active ingredients. The active ingredients of...
21 CFR 346.10 - Local anesthetic active ingredients.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Local anesthetic active ingredients. 346.10... (CONTINUED) DRUGS FOR HUMAN USE ANORECTAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 346.10 Local anesthetic active ingredients. The active ingredient of the product consists of any of...
21 CFR 341.14 - Antitussive active ingredients.
Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Antitussive active ingredients. 341.14 Section 341.14 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED...-COUNTER HUMAN USE Active Ingredients § 341.14 Antitussive active ingredients. The active ingredients of...
21 CFR 341.12 - Antihistamine active ingredients.
Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Antihistamine active ingredients. 341.12 Section 341.12 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED...-COUNTER HUMAN USE Active Ingredients § 341.12 Antihistamine active ingredients. The active ingredient of...
21 CFR 341.18 - Expectorant active ingredient.
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Expectorant active ingredient. 341.18 Section 341.18 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED...-COUNTER HUMAN USE Active Ingredients § 341.18 Expectorant active ingredient. The active ingredient of the...
21 CFR 341.20 - Nasal decongestant active ingredients.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Nasal decongestant active ingredients. 341.20... OVER-THE-COUNTER HUMAN USE Active Ingredients § 341.20 Nasal decongestant active ingredients. The active ingredient of the product consists of any of the following when used within the dosage limits and...
21 CFR 346.10 - Local anesthetic active ingredients.
Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Local anesthetic active ingredients. 346.10... (CONTINUED) DRUGS FOR HUMAN USE ANORECTAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 346.10 Local anesthetic active ingredients. The active ingredient of the product consists of any of...
21 CFR 335.10 - Antidiarrheal active ingredients.
Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Antidiarrheal active ingredients. 335.10 Section...) DRUGS FOR HUMAN USE ANTIDIARRHEAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 335.10 Antidiarrheal active ingredients. The active ingredient of the product consists of any one of the...
21 CFR 341.16 - Bronchodilator active ingredients.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Bronchodilator active ingredients. 341.16 Section 341.16 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED...-COUNTER HUMAN USE Active Ingredients § 341.16 Bronchodilator active ingredients. The active ingredients of...
21 CFR 341.20 - Nasal decongestant active ingredients.
Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Nasal decongestant active ingredients. 341.20... OVER-THE-COUNTER HUMAN USE Active Ingredients § 341.20 Nasal decongestant active ingredients. The active ingredient of the product consists of any of the following when used within the dosage limits and...
21 CFR 341.12 - Antihistamine active ingredients.
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Antihistamine active ingredients. 341.12 Section 341.12 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED...-COUNTER HUMAN USE Active Ingredients § 341.12 Antihistamine active ingredients. The active ingredient of...
21 CFR 346.12 - Vasoconstrictor active ingredients.
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Vasoconstrictor active ingredients. 346.12 Section...) DRUGS FOR HUMAN USE ANORECTAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 346.12 Vasoconstrictor active ingredients. The active ingredient of the product consists of any of the following when...
21 CFR 335.10 - Antidiarrheal active ingredients.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Antidiarrheal active ingredients. 335.10 Section...) DRUGS FOR HUMAN USE ANTIDIARRHEAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 335.10 Antidiarrheal active ingredients. The active ingredient of the product consists of any one of the...
21 CFR 346.12 - Vasoconstrictor active ingredients.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Vasoconstrictor active ingredients. 346.12 Section...) DRUGS FOR HUMAN USE ANORECTAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 346.12 Vasoconstrictor active ingredients. The active ingredient of the product consists of any of the following when...
21 CFR 346.12 - Vasoconstrictor active ingredients.
Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Vasoconstrictor active ingredients. 346.12 Section...) DRUGS FOR HUMAN USE ANORECTAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 346.12 Vasoconstrictor active ingredients. The active ingredient of the product consists of any of the following when...
21 CFR 341.16 - Bronchodilator active ingredients.
Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Bronchodilator active ingredients. 341.16 Section 341.16 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED...-COUNTER HUMAN USE Active Ingredients § 341.16 Bronchodilator active ingredients. The active ingredients of...
21 CFR 346.10 - Local anesthetic active ingredients.
Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Local anesthetic active ingredients. 346.10... (CONTINUED) DRUGS FOR HUMAN USE ANORECTAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 346.10 Local anesthetic active ingredients. The active ingredient of the product consists of any of...
21 CFR 341.14 - Antitussive active ingredients.
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Antitussive active ingredients. 341.14 Section 341.14 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED...-COUNTER HUMAN USE Active Ingredients § 341.14 Antitussive active ingredients. The active ingredients of...
21 CFR 335.10 - Antidiarrheal active ingredients.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Antidiarrheal active ingredients. 335.10 Section...) DRUGS FOR HUMAN USE ANTIDIARRHEAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 335.10 Antidiarrheal active ingredients. The active ingredient of the product consists of any one of the...
21 CFR 346.12 - Vasoconstrictor active ingredients.
Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Vasoconstrictor active ingredients. 346.12 Section...) DRUGS FOR HUMAN USE ANORECTAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 346.12 Vasoconstrictor active ingredients. The active ingredient of the product consists of any of the following when...
21 CFR 341.18 - Expectorant active ingredient.
Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Expectorant active ingredient. 341.18 Section 341.18 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED...-COUNTER HUMAN USE Active Ingredients § 341.18 Expectorant active ingredient. The active ingredient of the...
21 CFR 331.11 - Listing of specific active ingredients.
Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Listing of specific active ingredients. 331.11... (CONTINUED) DRUGS FOR HUMAN USE ANTACID PRODUCTS FOR OVER-THE-COUNTER (OTC) HUMAN USE Active Ingredients § 331.11 Listing of specific active ingredients. (a) Aluminum-containing active ingredients: (1) Basic...
21 CFR 341.14 - Antitussive active ingredients.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Antitussive active ingredients. 341.14 Section 341.14 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED...-COUNTER HUMAN USE Active Ingredients § 341.14 Antitussive active ingredients. The active ingredients of...
21 CFR 341.16 - Bronchodilator active ingredients.
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Bronchodilator active ingredients. 341.16 Section 341.16 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED...-COUNTER HUMAN USE Active Ingredients § 341.16 Bronchodilator active ingredients. The active ingredients of...
21 CFR 341.12 - Antihistamine active ingredients.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Antihistamine active ingredients. 341.12 Section 341.12 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED...-COUNTER HUMAN USE Active Ingredients § 341.12 Antihistamine active ingredients. The active ingredient of...
21 CFR 350.10 - Antiperspirant active ingredients.
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Antiperspirant active ingredients. 350.10 Section...) DRUGS FOR HUMAN USE ANTIPERSPIRANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 350.10 Antiperspirant active ingredients. The active ingredient of the product consists of any of the...
21 CFR 350.10 - Antiperspirant active ingredients.
Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Antiperspirant active ingredients. 350.10 Section...) DRUGS FOR HUMAN USE ANTIPERSPIRANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 350.10 Antiperspirant active ingredients. The active ingredient of the product consists of any of the...
21 CFR 350.10 - Antiperspirant active ingredients.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Antiperspirant active ingredients. 350.10 Section...) DRUGS FOR HUMAN USE ANTIPERSPIRANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 350.10 Antiperspirant active ingredients. The active ingredient of the product consists of any of the...
21 CFR 350.10 - Antiperspirant active ingredients.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Antiperspirant active ingredients. 350.10 Section...) DRUGS FOR HUMAN USE ANTIPERSPIRANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 350.10 Antiperspirant active ingredients. The active ingredient of the product consists of any of the...
21 CFR 350.10 - Antiperspirant active ingredients.
Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Antiperspirant active ingredients. 350.10 Section...) DRUGS FOR HUMAN USE ANTIPERSPIRANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 350.10 Antiperspirant active ingredients. The active ingredient of the product consists of any of the...
Network Understanding of Herb Medicine via Rapid Identification of Ingredient-Target Interactions
NASA Astrophysics Data System (ADS)
Zhang, Hai-Ping; Pan, Jian-Bo; Zhang, Chi; Ji, Nan; Wang, Hao; Ji, Zhi-Liang
2014-01-01
Today, herb medicines have become the major source for discovery of novel agents in countermining diseases. However, many of them are largely under-explored in pharmacology due to the limitation of current experimental approaches. Therefore, we proposed a computational framework in this study for network understanding of herb pharmacology via rapid identification of putative ingredient-target interactions in human structural proteome level. A marketing anti-cancer herb medicine in China, Yadanzi (Brucea javanica), was chosen for mechanistic study. Total 7,119 ingredient-target interactions were identified for thirteen Yadanzi active ingredients. Among them, about 29.5% were estimated to have better binding affinity than their corresponding marketing drug-target interactions. Further Bioinformatics analyses suggest that simultaneous manipulation of multiple proteins in the MAPK signaling pathway and the phosphorylation process of anti-apoptosis may largely answer for Yadanzi against non-small cell lung cancers. In summary, our strategy provides an efficient however economic solution for systematic understanding of herbs' power.
Network understanding of herb medicine via rapid identification of ingredient-target interactions.
Zhang, Hai-Ping; Pan, Jian-Bo; Zhang, Chi; Ji, Nan; Wang, Hao; Ji, Zhi-Liang
2014-01-16
Today, herb medicines have become the major source for discovery of novel agents in countermining diseases. However, many of them are largely under-explored in pharmacology due to the limitation of current experimental approaches. Therefore, we proposed a computational framework in this study for network understanding of herb pharmacology via rapid identification of putative ingredient-target interactions in human structural proteome level. A marketing anti-cancer herb medicine in China, Yadanzi (Brucea javanica), was chosen for mechanistic study. Total 7,119 ingredient-target interactions were identified for thirteen Yadanzi active ingredients. Among them, about 29.5% were estimated to have better binding affinity than their corresponding marketing drug-target interactions. Further Bioinformatics analyses suggest that simultaneous manipulation of multiple proteins in the MAPK signaling pathway and the phosphorylation process of anti-apoptosis may largely answer for Yadanzi against non-small cell lung cancers. In summary, our strategy provides an efficient however economic solution for systematic understanding of herbs' power.
Minimum Risk Pesticides - Inert Ingredient and Active Ingredient Eligibility under 40 CFR 152.25(f)
Ingredients found on both the Minimum Risk Active Ingredient and List 4A Inert Ingredients of Minimal Concern lists may be used either as an active or an inert ingredient. Otherwise, it can only be used based on the list it appears on.
21 CFR 336.10 - Antiemetic active ingredients.
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Antiemetic active ingredients. 336.10 Section 336...) DRUGS FOR HUMAN USE ANTIEMETIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 336.10 Antiemetic active ingredients. The active ingredient of the product consists of any of the following when...
21 CFR 340.10 - Stimulant active ingredient.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Stimulant active ingredient. 340.10 Section 340.10... FOR HUMAN USE STIMULANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredient § 340.10 Stimulant active ingredient. The active ingredient of the product consists of caffeine when used within the...
21 CFR 347.12 - Astringent active ingredients.
Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Astringent active ingredients. 347.12 Section 347...) DRUGS FOR HUMAN USE SKIN PROTECTANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 347.12 Astringent active ingredients. The active ingredient of the product consists of any one of the...
21 CFR 346.18 - Astringent active ingredients.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Astringent active ingredients. 346.18 Section 346...) DRUGS FOR HUMAN USE ANORECTAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 346.18 Astringent active ingredients. The active ingredient of the product consists of any of the following when...
21 CFR 331.10 - Antacid active ingredients.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Antacid active ingredients. 331.10 Section 331.10... FOR HUMAN USE ANTACID PRODUCTS FOR OVER-THE-COUNTER (OTC) HUMAN USE Active Ingredients § 331.10 Antacid active ingredients. (a) The active antacid ingredients of the product consist of one or more of...
21 CFR 355.10 - Anticaries active ingredients.
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Anticaries active ingredients. 355.10 Section 355...) DRUGS FOR HUMAN USE ANTICARIES DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 355.10 Anticaries active ingredients. The active ingredient of the product consists of any of the following when...
21 CFR 346.18 - Astringent active ingredients.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Astringent active ingredients. 346.18 Section 346...) DRUGS FOR HUMAN USE ANORECTAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 346.18 Astringent active ingredients. The active ingredient of the product consists of any of the following when...
21 CFR 344.12 - Ear drying aid active ingredient.
Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Ear drying aid active ingredient. 344.12 Section...) DRUGS FOR HUMAN USE TOPICAL OTIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 344.12 Ear drying aid active ingredient. The active ingredient of the product consists of isopropyl...
21 CFR 355.10 - Anticaries active ingredients.
Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Anticaries active ingredients. 355.10 Section 355...) DRUGS FOR HUMAN USE ANTICARIES DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 355.10 Anticaries active ingredients. The active ingredient of the product consists of any of the following when...
21 CFR 346.20 - Keratolytic active ingredients.
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Keratolytic active ingredients. 346.20 Section 346...) DRUGS FOR HUMAN USE ANORECTAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 346.20 Keratolytic active ingredients. The active ingredient of the product consists of any of the following when...
21 CFR 344.10 - Earwax removal aid active ingredient.
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Earwax removal aid active ingredient. 344.10... (CONTINUED) DRUGS FOR HUMAN USE TOPICAL OTIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 344.10 Earwax removal aid active ingredient. The active ingredient of the product consists of...
21 CFR 344.12 - Ear drying aid active ingredient.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Ear drying aid active ingredient. 344.12 Section...) DRUGS FOR HUMAN USE TOPICAL OTIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 344.12 Ear drying aid active ingredient. The active ingredient of the product consists of isopropyl...
21 CFR 336.10 - Antiemetic active ingredients.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Antiemetic active ingredients. 336.10 Section 336...) DRUGS FOR HUMAN USE ANTIEMETIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 336.10 Antiemetic active ingredients. The active ingredient of the product consists of any of the following when...
21 CFR 355.10 - Anticaries active ingredients.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Anticaries active ingredients. 355.10 Section 355...) DRUGS FOR HUMAN USE ANTICARIES DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 355.10 Anticaries active ingredients. The active ingredient of the product consists of any of the following when...
21 CFR 346.20 - Keratolytic active ingredients.
Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Keratolytic active ingredients. 346.20 Section 346...) DRUGS FOR HUMAN USE ANORECTAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 346.20 Keratolytic active ingredients. The active ingredient of the product consists of any of the following when...
21 CFR 336.10 - Antiemetic active ingredients.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Antiemetic active ingredients. 336.10 Section 336...) DRUGS FOR HUMAN USE ANTIEMETIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 336.10 Antiemetic active ingredients. The active ingredient of the product consists of any of the following when...
21 CFR 331.10 - Antacid active ingredients.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Antacid active ingredients. 331.10 Section 331.10... FOR HUMAN USE ANTACID PRODUCTS FOR OVER-THE-COUNTER (OTC) HUMAN USE Active Ingredients § 331.10 Antacid active ingredients. (a) The active antacid ingredients of the product consist of one or more of...
21 CFR 355.10 - Anticaries active ingredients.
Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Anticaries active ingredients. 355.10 Section 355...) DRUGS FOR HUMAN USE ANTICARIES DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 355.10 Anticaries active ingredients. The active ingredient of the product consists of any of the following when...
21 CFR 331.10 - Antacid active ingredients.
Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Antacid active ingredients. 331.10 Section 331.10... FOR HUMAN USE ANTACID PRODUCTS FOR OVER-THE-COUNTER (OTC) HUMAN USE Active Ingredients § 331.10 Antacid active ingredients. (a) The active antacid ingredients of the product consist of one or more of...
21 CFR 344.12 - Ear drying aid active ingredient.
Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Ear drying aid active ingredient. 344.12 Section...) DRUGS FOR HUMAN USE TOPICAL OTIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 344.12 Ear drying aid active ingredient. The active ingredient of the product consists of isopropyl...
21 CFR 346.20 - Keratolytic active ingredients.
Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Keratolytic active ingredients. 346.20 Section 346...) DRUGS FOR HUMAN USE ANORECTAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 346.20 Keratolytic active ingredients. The active ingredient of the product consists of any of the following when...
21 CFR 340.10 - Stimulant active ingredient.
Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Stimulant active ingredient. 340.10 Section 340.10... FOR HUMAN USE STIMULANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredient § 340.10 Stimulant active ingredient. The active ingredient of the product consists of caffeine when used within the...
21 CFR 344.10 - Earwax removal aid active ingredient.
Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Earwax removal aid active ingredient. 344.10... (CONTINUED) DRUGS FOR HUMAN USE TOPICAL OTIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 344.10 Earwax removal aid active ingredient. The active ingredient of the product consists of...
21 CFR 331.10 - Antacid active ingredients.
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Antacid active ingredients. 331.10 Section 331.10... FOR HUMAN USE ANTACID PRODUCTS FOR OVER-THE-COUNTER (OTC) HUMAN USE Active Ingredients § 331.10 Antacid active ingredients. (a) The active antacid ingredients of the product consist of one or more of...
21 CFR 344.10 - Earwax removal aid active ingredient.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Earwax removal aid active ingredient. 344.10... (CONTINUED) DRUGS FOR HUMAN USE TOPICAL OTIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 344.10 Earwax removal aid active ingredient. The active ingredient of the product consists of...
21 CFR 346.18 - Astringent active ingredients.
Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Astringent active ingredients. 346.18 Section 346...) DRUGS FOR HUMAN USE ANORECTAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 346.18 Astringent active ingredients. The active ingredient of the product consists of any of the following when...
21 CFR 344.12 - Ear drying aid active ingredient.
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Ear drying aid active ingredient. 344.12 Section...) DRUGS FOR HUMAN USE TOPICAL OTIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 344.12 Ear drying aid active ingredient. The active ingredient of the product consists of isopropyl...
21 CFR 346.20 - Keratolytic active ingredients.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Keratolytic active ingredients. 346.20 Section 346...) DRUGS FOR HUMAN USE ANORECTAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 346.20 Keratolytic active ingredients. The active ingredient of the product consists of any of the following when...
21 CFR 347.12 - Astringent active ingredients.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Astringent active ingredients. 347.12 Section 347...) DRUGS FOR HUMAN USE SKIN PROTECTANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 347.12 Astringent active ingredients. The active ingredient of the product consists of any one of the...
21 CFR 344.12 - Ear drying aid active ingredient.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Ear drying aid active ingredient. 344.12 Section...) DRUGS FOR HUMAN USE TOPICAL OTIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 344.12 Ear drying aid active ingredient. The active ingredient of the product consists of isopropyl...
21 CFR 346.18 - Astringent active ingredients.
Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Astringent active ingredients. 346.18 Section 346...) DRUGS FOR HUMAN USE ANORECTAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 346.18 Astringent active ingredients. The active ingredient of the product consists of any of the following when...
21 CFR 346.18 - Astringent active ingredients.
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Astringent active ingredients. 346.18 Section 346...) DRUGS FOR HUMAN USE ANORECTAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 346.18 Astringent active ingredients. The active ingredient of the product consists of any of the following when...
21 CFR 344.10 - Earwax removal aid active ingredient.
Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Earwax removal aid active ingredient. 344.10... (CONTINUED) DRUGS FOR HUMAN USE TOPICAL OTIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 344.10 Earwax removal aid active ingredient. The active ingredient of the product consists of...
21 CFR 346.20 - Keratolytic active ingredients.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Keratolytic active ingredients. 346.20 Section 346...) DRUGS FOR HUMAN USE ANORECTAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 346.20 Keratolytic active ingredients. The active ingredient of the product consists of any of the following when...
21 CFR 336.10 - Antiemetic active ingredients.
Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Antiemetic active ingredients. 336.10 Section 336...) DRUGS FOR HUMAN USE ANTIEMETIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 336.10 Antiemetic active ingredients. The active ingredient of the product consists of any of the following when...
21 CFR 340.10 - Stimulant active ingredient.
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Stimulant active ingredient. 340.10 Section 340.10... FOR HUMAN USE STIMULANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredient § 340.10 Stimulant active ingredient. The active ingredient of the product consists of caffeine when used within the...
21 CFR 347.12 - Astringent active ingredients.
Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Astringent active ingredients. 347.12 Section 347...) DRUGS FOR HUMAN USE SKIN PROTECTANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 347.12 Astringent active ingredients. The active ingredient of the product consists of any one of the...
21 CFR 347.12 - Astringent active ingredients.
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Astringent active ingredients. 347.12 Section 347...) DRUGS FOR HUMAN USE SKIN PROTECTANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 347.12 Astringent active ingredients. The active ingredient of the product consists of any one of the...
21 CFR 331.10 - Antacid active ingredients.
Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Antacid active ingredients. 331.10 Section 331.10... FOR HUMAN USE ANTACID PRODUCTS FOR OVER-THE-COUNTER (OTC) HUMAN USE Active Ingredients § 331.10 Antacid active ingredients. (a) The active antacid ingredients of the product consist of one or more of...
21 CFR 355.10 - Anticaries active ingredients.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Anticaries active ingredients. 355.10 Section 355...) DRUGS FOR HUMAN USE ANTICARIES DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 355.10 Anticaries active ingredients. The active ingredient of the product consists of any of the following when...
21 CFR 340.10 - Stimulant active ingredient.
Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Stimulant active ingredient. 340.10 Section 340.10... FOR HUMAN USE STIMULANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredient § 340.10 Stimulant active ingredient. The active ingredient of the product consists of caffeine when used within the...
21 CFR 336.10 - Antiemetic active ingredients.
Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Antiemetic active ingredients. 336.10 Section 336...) DRUGS FOR HUMAN USE ANTIEMETIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 336.10 Antiemetic active ingredients. The active ingredient of the product consists of any of the following when...
21 CFR 344.10 - Earwax removal aid active ingredient.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Earwax removal aid active ingredient. 344.10... (CONTINUED) DRUGS FOR HUMAN USE TOPICAL OTIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 344.10 Earwax removal aid active ingredient. The active ingredient of the product consists of...
21 CFR 338.10 - Nighttime sleep-aid active ingredients.
Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Nighttime sleep-aid active ingredients. 338.10... (CONTINUED) DRUGS FOR HUMAN USE NIGHTTIME SLEEP-AID DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 338.10 Nighttime sleep-aid active ingredients. The active ingredient of the product consists of...
21 CFR 338.10 - Nighttime sleep-aid active ingredients.
Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Nighttime sleep-aid active ingredients. 338.10... (CONTINUED) DRUGS FOR HUMAN USE NIGHTTIME SLEEP-AID DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 338.10 Nighttime sleep-aid active ingredients. The active ingredient of the product consists of...
21 CFR 338.10 - Nighttime sleep-aid active ingredients.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Nighttime sleep-aid active ingredients. 338.10... (CONTINUED) DRUGS FOR HUMAN USE NIGHTTIME SLEEP-AID DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 338.10 Nighttime sleep-aid active ingredients. The active ingredient of the product consists of...
21 CFR 338.10 - Nighttime sleep-aid active ingredients.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Nighttime sleep-aid active ingredients. 338.10... (CONTINUED) DRUGS FOR HUMAN USE NIGHTTIME SLEEP-AID DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 338.10 Nighttime sleep-aid active ingredients. The active ingredient of the product consists of...
21 CFR 338.10 - Nighttime sleep-aid active ingredients.
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Nighttime sleep-aid active ingredients. 338.10... (CONTINUED) DRUGS FOR HUMAN USE NIGHTTIME SLEEP-AID DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 338.10 Nighttime sleep-aid active ingredients. The active ingredient of the product consists of...
Cheng, Jian; Di, Liu-Qing; Shan, Jin-Jun; Zhao, Xiao-Li; Kang, An; Bi, Xiao-Lin; Li, Jun-Song
2014-04-01
To study on the effects of Achyranthes bidentata on Tongsaimai pellets main active ingredients chlorogenic acid, isoliquiritin, harpagoside and glycyrrhizin in rats in vivo pharmacokinetic behaviors, a method for the simultaneous determination of chlorogenic acid, isoliquiritin, harpagoside and liquiritigenin in rat plasma was established by UPLC-MS/MS. The analysis was performed on a waters Acquity BEH C18 column (2.1 mm x 100 mm, 1.7 microm) with the mixture of acetonitrile and 0.1% formic acid/water as mobile phase, and the gradient elution at a flow rate of 0.3 mL x min(-1). The analytes were detected by tandem mass spectrometry with the electrospray ionization (ESI) source and in the multiple reaction monitoring (MRM) mode. It turned out that the analytes of Tongsaimai pellets groups C(max) and AUC(Q-infinity) values were higher than that with A. bidentata group, and the C(max) values of chlorogenic acid had significantly difference (P < 0.05), the AUC(0-infinity) values of chlorogenic acid and glycyrrhizin had significantly difference (P < 0.05); The T(max) and CL values of two groups had no significantly difference. Results showed that the established method was specific, rapid, accurate and sensitive for the studies of Tongsaimai pellets four main active ingredients in rat in vivo pharmacokinetic, and A. bidentata have varying degrees of effects on Tongsaimai pellets four main active ingredients in rat in vivo pharmacokinetic behaviors.
21 CFR 346.16 - Analgesic, anesthetic, and antipruritic active ingredients.
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Analgesic, anesthetic, and antipruritic active ingredients. 346.16 Section 346.16 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... Ingredients § 346.16 Analgesic, anesthetic, and antipruritic active ingredients. The active ingredient of the...
21 CFR 346.16 - Analgesic, anesthetic, and antipruritic active ingredients.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Analgesic, anesthetic, and antipruritic active ingredients. 346.16 Section 346.16 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... Ingredients § 346.16 Analgesic, anesthetic, and antipruritic active ingredients. The active ingredient of the...
21 CFR 343.13 - Rheumatologic active ingredients.
Code of Federal Regulations, 2014 CFR
2014-04-01
...-COUNTER HUMAN USE Active Ingredients § 343.13 Rheumatologic active ingredients. (a) Aspirin. (b) Buffered aspirin. Aspirin identified in paragraph (a) of this section may be buffered with any antacid ingredient(s... milliequivalents of acid-neutralizing capacity per 325 milligrams of aspirin as measured by the procedure provided...
21 CFR 343.13 - Rheumatologic active ingredients.
Code of Federal Regulations, 2012 CFR
2012-04-01
...-COUNTER HUMAN USE Active Ingredients § 343.13 Rheumatologic active ingredients. (a) Aspirin. (b) Buffered aspirin. Aspirin identified in paragraph (a) of this section may be buffered with any antacid ingredient(s... milliequivalents of acid-neutralizing capacity per 325 milligrams of aspirin as measured by the procedure provided...
21 CFR 343.12 - Cardiovascular active ingredients.
Code of Federal Regulations, 2014 CFR
2014-04-01
...-COUNTER HUMAN USE Active Ingredients § 343.12 Cardiovascular active ingredients. (a) Aspirin. (b) Buffered aspirin. Aspirin identified in paragraph (a) of this section may be buffered with any antacid ingredient(s... milliequivalents of acid-neutralizing capacity per 325 milligrams of aspirin as measured by the procedure provided...
21 CFR 343.13 - Rheumatologic active ingredients.
Code of Federal Regulations, 2011 CFR
2011-04-01
...-COUNTER HUMAN USE Active Ingredients § 343.13 Rheumatologic active ingredients. (a) Aspirin. (b) Buffered aspirin. Aspirin identified in paragraph (a) of this section may be buffered with any antacid ingredient(s... milliequivalents of acid-neutralizing capacity per 325 milligrams of aspirin as measured by the procedure provided...
21 CFR 343.13 - Rheumatologic active ingredients.
Code of Federal Regulations, 2010 CFR
2010-04-01
...-COUNTER HUMAN USE Active Ingredients § 343.13 Rheumatologic active ingredients. (a) Aspirin. (b) Buffered aspirin. Aspirin identified in paragraph (a) of this section may be buffered with any antacid ingredient(s... milliequivalents of acid-neutralizing capacity per 325 milligrams of aspirin as measured by the procedure provided...
21 CFR 343.12 - Cardiovascular active ingredients.
Code of Federal Regulations, 2011 CFR
2011-04-01
...-COUNTER HUMAN USE Active Ingredients § 343.12 Cardiovascular active ingredients. (a) Aspirin. (b) Buffered aspirin. Aspirin identified in paragraph (a) of this section may be buffered with any antacid ingredient(s... milliequivalents of acid-neutralizing capacity per 325 milligrams of aspirin as measured by the procedure provided...
21 CFR 343.12 - Cardiovascular active ingredients.
Code of Federal Regulations, 2013 CFR
2013-04-01
...-COUNTER HUMAN USE Active Ingredients § 343.12 Cardiovascular active ingredients. (a) Aspirin. (b) Buffered aspirin. Aspirin identified in paragraph (a) of this section may be buffered with any antacid ingredient(s... milliequivalents of acid-neutralizing capacity per 325 milligrams of aspirin as measured by the procedure provided...
21 CFR 343.12 - Cardiovascular active ingredients.
Code of Federal Regulations, 2010 CFR
2010-04-01
...-COUNTER HUMAN USE Active Ingredients § 343.12 Cardiovascular active ingredients. (a) Aspirin. (b) Buffered aspirin. Aspirin identified in paragraph (a) of this section may be buffered with any antacid ingredient(s... milliequivalents of acid-neutralizing capacity per 325 milligrams of aspirin as measured by the procedure provided...
21 CFR 343.13 - Rheumatologic active ingredients.
Code of Federal Regulations, 2013 CFR
2013-04-01
...-COUNTER HUMAN USE Active Ingredients § 343.13 Rheumatologic active ingredients. (a) Aspirin. (b) Buffered aspirin. Aspirin identified in paragraph (a) of this section may be buffered with any antacid ingredient(s... milliequivalents of acid-neutralizing capacity per 325 milligrams of aspirin as measured by the procedure provided...
21 CFR 343.12 - Cardiovascular active ingredients.
Code of Federal Regulations, 2012 CFR
2012-04-01
...-COUNTER HUMAN USE Active Ingredients § 343.12 Cardiovascular active ingredients. (a) Aspirin. (b) Buffered aspirin. Aspirin identified in paragraph (a) of this section may be buffered with any antacid ingredient(s... milliequivalents of acid-neutralizing capacity per 325 milligrams of aspirin as measured by the procedure provided...
Code of Federal Regulations, 2014 CFR
2014-07-01
..., active ingredient, or device is produced, regardless of whether such site is independently owned or... PESTICIDE AND ACTIVE INGREDIENT PRODUCING ESTABLISHMENTS, SUBMISSION OF PESTICIDE REPORTS General Provisions... active ingredients or gallons for liquid pesticides and active ingredients, or number of individual...
Code of Federal Regulations, 2013 CFR
2013-07-01
..., active ingredient, or device is produced, regardless of whether such site is independently owned or... PESTICIDE AND ACTIVE INGREDIENT PRODUCING ESTABLISHMENTS, SUBMISSION OF PESTICIDE REPORTS General Provisions... active ingredients or gallons for liquid pesticides and active ingredients, or number of individual...
Code of Federal Regulations, 2012 CFR
2012-07-01
..., active ingredient, or device is produced, regardless of whether such site is independently owned or... PESTICIDE AND ACTIVE INGREDIENT PRODUCING ESTABLISHMENTS, SUBMISSION OF PESTICIDE REPORTS General Provisions... active ingredients or gallons for liquid pesticides and active ingredients, or number of individual...
Code of Federal Regulations, 2011 CFR
2011-07-01
... PESTICIDE AND ACTIVE INGREDIENT PRODUCING ESTABLISHMENTS, SUBMISSION OF PESTICIDE REPORTS General Provisions... active ingredients or gallons for liquid pesticides and active ingredients, or number of individual..., active ingredient, or device is produced, regardless of whether such site is independently owned or...
Code of Federal Regulations, 2010 CFR
2010-07-01
... PESTICIDE AND ACTIVE INGREDIENT PRODUCING ESTABLISHMENTS, SUBMISSION OF PESTICIDE REPORTS General Provisions... active ingredients or gallons for liquid pesticides and active ingredients, or number of individual..., active ingredient, or device is produced, regardless of whether such site is independently owned or...
21 CFR 358.720 - Permitted combinations of active ingredients.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Permitted combinations of active ingredients. 358... Permitted combinations of active ingredients. (a) Combination of active ingredients for the control of... labeled according to § 358.750. (b) Combination of control of dandruff and external analgesic active...
21 CFR 348.10 - Analgesic, anesthetic, and antipruritic active ingredients.
Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Analgesic, anesthetic, and antipruritic active ingredients. 348.10 Section 348.10 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... Active Ingredients § 348.10 Analgesic, anesthetic, and antipruritic active ingredients. The active...
21 CFR 358.720 - Permitted combinations of active ingredients.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Permitted combinations of active ingredients. 358... Permitted combinations of active ingredients. (a) Combination of active ingredients for the control of... labeled according to § 358.750. (b) Combination of control of dandruff and external analgesic active...
21 CFR 358.720 - Permitted combinations of active ingredients.
Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Permitted combinations of active ingredients. 358... Permitted combinations of active ingredients. (a) Combination of active ingredients for the control of... labeled according to § 358.750. (b) Combination of control of dandruff and external analgesic active...
21 CFR 358.720 - Permitted combinations of active ingredients.
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Permitted combinations of active ingredients. 358... Permitted combinations of active ingredients. (a) Combination of active ingredients for the control of... labeled according to § 358.750. (b) Combination of control of dandruff and external analgesic active...
21 CFR 346.16 - Analgesic, anesthetic, and antipruritic active ingredients.
Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Analgesic, anesthetic, and antipruritic active... SERVICES (CONTINUED) DRUGS FOR HUMAN USE ANORECTAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 346.16 Analgesic, anesthetic, and antipruritic active ingredients. The active ingredient of the...
21 CFR 348.10 - Analgesic, anesthetic, and antipruritic active ingredients.
Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Analgesic, anesthetic, and antipruritic active ingredients. 348.10 Section 348.10 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... Active Ingredients § 348.10 Analgesic, anesthetic, and antipruritic active ingredients. The active...
21 CFR 346.16 - Analgesic, anesthetic, and antipruritic active ingredients.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Analgesic, anesthetic, and antipruritic active... SERVICES (CONTINUED) DRUGS FOR HUMAN USE ANORECTAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 346.16 Analgesic, anesthetic, and antipruritic active ingredients. The active ingredient of the...
21 CFR 358.720 - Permitted combinations of active ingredients.
Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Permitted combinations of active ingredients. 358... Permitted combinations of active ingredients. (a) Combination of active ingredients for the control of... labeled according to § 358.750. (b) Combination of control of dandruff and external analgesic active...
21 CFR 348.10 - Analgesic, anesthetic, and antipruritic active ingredients.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Analgesic, anesthetic, and antipruritic active ingredients. 348.10 Section 348.10 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... Active Ingredients § 348.10 Analgesic, anesthetic, and antipruritic active ingredients. The active...
21 CFR 346.16 - Analgesic, anesthetic, and antipruritic active ingredients.
Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Analgesic, anesthetic, and antipruritic active... SERVICES (CONTINUED) DRUGS FOR HUMAN USE ANORECTAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 346.16 Analgesic, anesthetic, and antipruritic active ingredients. The active ingredient of the...
21 CFR 348.10 - Analgesic, anesthetic, and antipruritic active ingredients.
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Analgesic, anesthetic, and antipruritic active ingredients. 348.10 Section 348.10 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... Active Ingredients § 348.10 Analgesic, anesthetic, and antipruritic active ingredients. The active...
21 CFR 348.10 - Analgesic, anesthetic, and antipruritic active ingredients.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Analgesic, anesthetic, and antipruritic active ingredients. 348.10 Section 348.10 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... Active Ingredients § 348.10 Analgesic, anesthetic, and antipruritic active ingredients. The active...
Li, Jing-hui; Łuczka, Jerzy
2010-10-01
Transport properties of a Brownian particle in thermal-inertial ratchets subject to an external time-oscillatory drive and a constant bias force are investigated. Since the phenomena of negative mobility, resonant activation and noise-enhance stability were reported before, in the present paper, we report some additional aspects of negative mobility, resonant activation and noise-enhance stability, such as the ingredients for the appearances of these phenomena, multiple resonant activation peaks, current reversals, noise-weakened stability, and so on.
21 CFR 346.14 - Protectant active ingredients.
Code of Federal Regulations, 2010 CFR
2010-04-01
...) DRUGS FOR HUMAN USE ANORECTAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 346.14... ingredient in a product if the ingredient as identified constitutes 50 percent or more by weight of the final product. In addition, the following active ingredients may be used in concentrations of less than 50...
77 FR 48519 - Registration Applications for Pesticide Products Containing New Active Ingredients
Federal Register 2010, 2011, 2012, 2013, 2014
2012-08-14
... Pesticide Products Containing New Active Ingredients AGENCY: Environmental Protection Agency (EPA). ACTION... new active ingredients not included in any currently registered products pursuant to the provisions of... as follows to register pesticide products containing active ingredients not included in any...
Safety Assessment of Panax spp Root-Derived Ingredients as Used in Cosmetics.
Becker, Lillian C; Bergfeld, Wilma F; Belsito, Donald V; Hill, Ronald A; Klaassen, Curtis D; Liebler, Daniel C; Marks, James G; Shank, Ronald C; Slaga, Thomas J; Snyder, Paul W; Andersen, F Alan
2015-01-01
The Cosmetic Ingredient Review Expert Panel (Panel) reviewed the safety of 13 Panax spp root-derived ingredients as used in cosmetics. Panax "spp" indicates that multiple species within the genus are used in cosmetics, but not all species within that genus. Four species are being considered in this safety assessment. These ingredients function mostly as skin-conditioning agents-miscellaneous, fragrance ingredients, skin-conditioning agents-humectant, skin-conditioning agents-emollient, and cosmetic astringents. The Panel reviewed available data related to these ingredients and addressed the issue of pulegone, a constituent of these ingredients and other ingredients, such as peppermint oil. The Panel concluded that these Panax spp root-derived ingredients are safe in the practices of use and concentration as given in this safety assessment. © The Author(s) 2015.
21 CFR 357.210 - Cholecystokinetic active ingredients.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Cholecystokinetic active ingredients. 357.210 Section 357.210 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... Cholecystokinetic Drug Products § 357.210 Cholecystokinetic active ingredients. The active ingredient of the product...
21 CFR 358.610 - Pediculicide active ingredients.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Pediculicide active ingredients. 358.610 Section 358.610 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... Pediculicide Drug Products § 358.610 Pediculicide active ingredients. The active ingredients of the product...
21 CFR 358.610 - Pediculicide active ingredients.
Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Pediculicide active ingredients. 358.610 Section 358.610 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... Pediculicide Drug Products § 358.610 Pediculicide active ingredients. The active ingredients of the product...
21 CFR 358.610 - Pediculicide active ingredients.
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Pediculicide active ingredients. 358.610 Section 358.610 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... Pediculicide Drug Products § 358.610 Pediculicide active ingredients. The active ingredients of the product...
21 CFR 357.210 - Cholecystokinetic active ingredients.
Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Cholecystokinetic active ingredients. 357.210 Section 357.210 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... Cholecystokinetic Drug Products § 357.210 Cholecystokinetic active ingredients. The active ingredient of the product...
21 CFR 358.610 - Pediculicide active ingredients.
Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Pediculicide active ingredients. 358.610 Section 358.610 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... Pediculicide Drug Products § 358.610 Pediculicide active ingredients. The active ingredients of the product...
21 CFR 358.610 - Pediculicide active ingredients.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Pediculicide active ingredients. 358.610 Section 358.610 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... Pediculicide Drug Products § 358.610 Pediculicide active ingredients. The active ingredients of the product...
21 CFR 357.210 - Cholecystokinetic active ingredients.
Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Cholecystokinetic active ingredients. 357.210 Section 357.210 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... Cholecystokinetic Drug Products § 357.210 Cholecystokinetic active ingredients. The active ingredient of the product...
21 CFR 331.15 - Combination with nonantacid active ingredients.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Combination with nonantacid active ingredients... SERVICES (CONTINUED) DRUGS FOR HUMAN USE ANTACID PRODUCTS FOR OVER-THE-COUNTER (OTC) HUMAN USE Active Ingredients § 331.15 Combination with nonantacid active ingredients. (a) An antacid may contain any generally...
21 CFR 332.10 - Antiflatulent active ingredients.
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Antiflatulent active ingredients. 332.10 Section...) DRUGS FOR HUMAN USE ANTIFLATULENT PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 332.10 Antiflatulent active ingredients. Simethicone; maximum daily dose 500 mg. There is no dosage limitation at this...
21 CFR 332.10 - Antiflatulent active ingredients.
Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Antiflatulent active ingredients. 332.10 Section...) DRUGS FOR HUMAN USE ANTIFLATULENT PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 332.10 Antiflatulent active ingredients. Simethicone; maximum daily dose 500 mg. There is no dosage limitation at this...
21 CFR 333.210 - Antifungal active ingredients.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Antifungal active ingredients. 333.210 Section 333.210 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED... Antifungal Drug Products § 333.210 Antifungal active ingredients. The active ingredient of the product...
78 FR 70043 - Pesticide Product Registration; Receipt of an Application for a New Active Ingredient
Federal Register 2010, 2011, 2012, 2013, 2014
2013-11-22
...; Receipt of an Application for a New Active Ingredient AGENCY: Environmental Protection Agency (EPA... active ingredient not included in any previously registered pesticide product. Pursuant to the Federal... Application EPA has received an application to register a pesticide product containing an active ingredient...
21 CFR 357.110 - Anthelmintic active ingredient.
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Anthelmintic active ingredient. 357.110 Section 357.110 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... Anthelmintic Drug Products § 357.110 Anthelmintic active ingredient. The active ingredient of the product is...
21 CFR 357.110 - Anthelmintic active ingredient.
Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Anthelmintic active ingredient. 357.110 Section 357.110 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... Anthelmintic Drug Products § 357.110 Anthelmintic active ingredient. The active ingredient of the product is...
21 CFR 332.10 - Antiflatulent active ingredients.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Antiflatulent active ingredients. 332.10 Section...) DRUGS FOR HUMAN USE ANTIFLATULENT PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 332.10 Antiflatulent active ingredients. Simethicone; maximum daily dose 500 mg. There is no dosage limitation at this...
21 CFR 332.10 - Antiflatulent active ingredients.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Antiflatulent active ingredients. 332.10 Section...) DRUGS FOR HUMAN USE ANTIFLATULENT PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 332.10 Antiflatulent active ingredients. Simethicone; maximum daily dose 500 mg. There is no dosage limitation at this...
21 CFR 333.210 - Antifungal active ingredients.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Antifungal active ingredients. 333.210 Section 333.210 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED... Antifungal Drug Products § 333.210 Antifungal active ingredients. The active ingredient of the product...
21 CFR 331.15 - Combination with nonantacid active ingredients.
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Combination with nonantacid active ingredients... SERVICES (CONTINUED) DRUGS FOR HUMAN USE ANTACID PRODUCTS FOR OVER-THE-COUNTER (OTC) HUMAN USE Active Ingredients § 331.15 Combination with nonantacid active ingredients. (a) An antacid may contain any generally...
21 CFR 358.110 - Wart remover active ingredients.
Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Wart remover active ingredients. 358.110 Section... Remover Drug Products § 358.110 Wart remover active ingredients. The product consists of any of the following active ingredients within the specified concentration and in the dosage form established for each...
21 CFR 349.30 - Permitted combinations of active ingredients.
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Permitted combinations of active ingredients. 349... SERVICES (CONTINUED) DRUGS FOR HUMAN USE OPHTHALMIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 349.30 Permitted combinations of active ingredients. The following combinations are permitted...
21 CFR 331.15 - Combination with nonantacid active ingredients.
Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Combination with nonantacid active ingredients... SERVICES (CONTINUED) DRUGS FOR HUMAN USE ANTACID PRODUCTS FOR OVER-THE-COUNTER (OTC) HUMAN USE Active Ingredients § 331.15 Combination with nonantacid active ingredients. (a) An antacid may contain any generally...
21 CFR 331.15 - Combination with nonantacid active ingredients.
Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Combination with nonantacid active ingredients... SERVICES (CONTINUED) DRUGS FOR HUMAN USE ANTACID PRODUCTS FOR OVER-THE-COUNTER (OTC) HUMAN USE Active Ingredients § 331.15 Combination with nonantacid active ingredients. (a) An antacid may contain any generally...
21 CFR 357.110 - Anthelmintic active ingredient.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Anthelmintic active ingredient. 357.110 Section 357.110 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... Anthelmintic Drug Products § 357.110 Anthelmintic active ingredient. The active ingredient of the product is...
21 CFR 358.110 - Wart remover active ingredients.
Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Wart remover active ingredients. 358.110 Section... Remover Drug Products § 358.110 Wart remover active ingredients. The product consists of any of the following active ingredients within the specified concentration and in the dosage form established for each...
21 CFR 332.10 - Antiflatulent active ingredients.
Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Antiflatulent active ingredients. 332.10 Section...) DRUGS FOR HUMAN USE ANTIFLATULENT PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 332.10 Antiflatulent active ingredients. Simethicone; maximum daily dose 500 mg. There is no dosage limitation at this...
21 CFR 358.110 - Wart remover active ingredients.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Wart remover active ingredients. 358.110 Section... Remover Drug Products § 358.110 Wart remover active ingredients. The product consists of any of the following active ingredients within the specified concentration and in the dosage form established for each...
21 CFR 358.110 - Wart remover active ingredients.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Wart remover active ingredients. 358.110 Section... Remover Drug Products § 358.110 Wart remover active ingredients. The product consists of any of the following active ingredients within the specified concentration and in the dosage form established for each...
21 CFR 349.30 - Permitted combinations of active ingredients.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Permitted combinations of active ingredients. 349... SERVICES (CONTINUED) DRUGS FOR HUMAN USE OPHTHALMIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 349.30 Permitted combinations of active ingredients. The following combinations are permitted...
21 CFR 349.30 - Permitted combinations of active ingredients.
Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Permitted combinations of active ingredients. 349... SERVICES (CONTINUED) DRUGS FOR HUMAN USE OPHTHALMIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 349.30 Permitted combinations of active ingredients. The following combinations are permitted...
21 CFR 358.110 - Wart remover active ingredients.
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Wart remover active ingredients. 358.110 Section... Remover Drug Products § 358.110 Wart remover active ingredients. The product consists of any of the following active ingredients within the specified concentration and in the dosage form established for each...
21 CFR 349.30 - Permitted combinations of active ingredients.
Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Permitted combinations of active ingredients. 349... SERVICES (CONTINUED) DRUGS FOR HUMAN USE OPHTHALMIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 349.30 Permitted combinations of active ingredients. The following combinations are permitted...
21 CFR 349.30 - Permitted combinations of active ingredients.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Permitted combinations of active ingredients. 349... SERVICES (CONTINUED) DRUGS FOR HUMAN USE OPHTHALMIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 349.30 Permitted combinations of active ingredients. The following combinations are permitted...
21 CFR 333.210 - Antifungal active ingredients.
Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Antifungal active ingredients. 333.210 Section 333.210 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED... Antifungal Drug Products § 333.210 Antifungal active ingredients. The active ingredient of the product...
21 CFR 333.210 - Antifungal active ingredients.
Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Antifungal active ingredients. 333.210 Section 333.210 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED... Antifungal Drug Products § 333.210 Antifungal active ingredients. The active ingredient of the product...
21 CFR 357.110 - Anthelmintic active ingredient.
Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Anthelmintic active ingredient. 357.110 Section 357.110 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... Anthelmintic Drug Products § 357.110 Anthelmintic active ingredient. The active ingredient of the product is...
21 CFR 357.110 - Anthelmintic active ingredient.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Anthelmintic active ingredient. 357.110 Section 357.110 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... Anthelmintic Drug Products § 357.110 Anthelmintic active ingredient. The active ingredient of the product is...
21 CFR 333.210 - Antifungal active ingredients.
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Antifungal active ingredients. 333.210 Section 333.210 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED... Antifungal Drug Products § 333.210 Antifungal active ingredients. The active ingredient of the product...
21 CFR 331.15 - Combination with nonantacid active ingredients.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Combination with nonantacid active ingredients... SERVICES (CONTINUED) DRUGS FOR HUMAN USE ANTACID PRODUCTS FOR OVER-THE-COUNTER (OTC) HUMAN USE Active Ingredients § 331.15 Combination with nonantacid active ingredients. (a) An antacid may contain any generally...
21 CFR 346.10 - Local anesthetic active ingredients.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Local anesthetic active ingredients. 346.10 Section 346.10 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... § 346.10 Local anesthetic active ingredients. The active ingredient of the product consists of any of...
21 CFR 346.10 - Local anesthetic active ingredients.
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Local anesthetic active ingredients. 346.10 Section 346.10 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... § 346.10 Local anesthetic active ingredients. The active ingredient of the product consists of any of...
21 CFR 347.20 - Permitted combinations of active ingredients.
Code of Federal Regulations, 2010 CFR
2010-04-01
... SERVICES (CONTINUED) DRUGS FOR HUMAN USE SKIN PROTECTANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 347.20 Permitted combinations of active ingredients. (a) Combinations of skin...) Combinations of skin protectant and external analgesic active ingredients. Any one (two when required to be in...
Active ingredients of substance use-focused self-help groups.
Moos, Rudolf H
2008-03-01
This paper provides an overview of some of the probable active ingredients of self-help groups in light of four related theories that identify common social processes that appear to underlie effective psychosocial treatments for and continuing remission from these disorders. Social control theory specifies active ingredients such as bonding, goal direction and structure; social learning theory specifies the importance of norms and role models, behavioral economics and behavioral choice theory emphasizes involvement in rewarding activities other than substance use, and stress and coping theory highlights building self-efficacy and effective coping skills. A review of existing studies suggests that the emphasis on these active ingredients probably underlies some aspects of the effectiveness of self-help groups. Several issues that need to be addressed to enhance understanding of the active ingredients of action of self-help groups are discussed, including consideration of indices of Alcoholics Anonymous (AA) affiliation as active ingredients, identification of personal characteristics that may moderate the influence of active ingredients on substance use outcomes, examination of whether active ingredients of self-help groups, can amplify or compensate for treatment, identification of potential detrimental effects of involvement in self-help groups and focusing on the link between active ingredients of self-help groups and other aspects of the overall recovery milieu, such as the family and social networks.
21 CFR 358.510 - Corn and callus remover active ingredients.
Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Corn and callus remover active ingredients. 358... USE Corn and Callus Remover Drug Products § 358.510 Corn and callus remover active ingredients. The product consists of any of the following active ingredients within the specified concentrations and in the...
21 CFR 358.510 - Corn and callus remover active ingredients.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Corn and callus remover active ingredients. 358... USE Corn and Callus Remover Drug Products § 358.510 Corn and callus remover active ingredients. The product consists of any of the following active ingredients within the specified concentrations and in the...
21 CFR 358.310 - Ingrown toenail relief active ingredient.
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Ingrown toenail relief active ingredient. 358.310 Section 358.310 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... Toenail Relief Drug Products § 358.310 Ingrown toenail relief active ingredient. The active ingredient of...
21 CFR 358.310 - Ingrown toenail relief active ingredient.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Ingrown toenail relief active ingredient. 358.310 Section 358.310 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... Toenail Relief Drug Products § 358.310 Ingrown toenail relief active ingredient. The active ingredient of...
21 CFR 333.310 - Acne active ingredients.
Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Acne active ingredients. 333.310 Section 333.310 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS... Products § 333.310 Acne active ingredients. The active ingredient of the product consists of any of the...
21 CFR 358.310 - Ingrown toenail relief active ingredient.
Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Ingrown toenail relief active ingredient. 358.310 Section 358.310 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... Toenail Relief Drug Products § 358.310 Ingrown toenail relief active ingredient. The active ingredient of...
21 CFR 358.510 - Corn and callus remover active ingredients.
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Corn and callus remover active ingredients. 358... USE Corn and Callus Remover Drug Products § 358.510 Corn and callus remover active ingredients. The product consists of any of the following active ingredients within the specified concentrations and in the...
21 CFR 333.310 - Acne active ingredients.
Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Acne active ingredients. 333.310 Section 333.310 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS... Products § 333.310 Acne active ingredients. The active ingredient of the product consists of any of the...
21 CFR 358.310 - Ingrown toenail relief active ingredient.
Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Ingrown toenail relief active ingredient. 358.310 Section 358.310 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... Toenail Relief Drug Products § 358.310 Ingrown toenail relief active ingredient. The active ingredient of...
21 CFR 358.310 - Ingrown toenail relief active ingredient.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Ingrown toenail relief active ingredient. 358.310 Section 358.310 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... Toenail Relief Drug Products § 358.310 Ingrown toenail relief active ingredient. The active ingredient of...
21 CFR 358.510 - Corn and callus remover active ingredients.
Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Corn and callus remover active ingredients. 358... USE Corn and Callus Remover Drug Products § 358.510 Corn and callus remover active ingredients. The product consists of any of the following active ingredients within the specified concentrations and in the...
21 CFR 333.310 - Acne active ingredients.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Acne active ingredients. 333.310 Section 333.310 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS... Products § 333.310 Acne active ingredients. The active ingredient of the product consists of any of the...
21 CFR 347.10 - Skin protectant active ingredients.
Code of Federal Regulations, 2010 CFR
2010-04-01
...) DRUGS FOR HUMAN USE SKIN PROTECTANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 347.10 Skin protectant active ingredients. The active ingredients of the product consist of any of the...) Aluminum hydroxide gel, 0.15 to 5 percent. (c) Calamine, 1 to 25 percent. (d) Cocoa butter, 50 to 100...
21 CFR 333.310 - Acne active ingredients.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Acne active ingredients. 333.310 Section 333.310... FOR HUMAN USE TOPICAL ANTIMICROBIAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Topical Acne Drug Products § 333.310 Acne active ingredients. The active ingredient of the product consists of any of the...
21 CFR 333.310 - Acne active ingredients.
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Acne active ingredients. 333.310 Section 333.310... FOR HUMAN USE TOPICAL ANTIMICROBIAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Topical Acne Drug Products § 333.310 Acne active ingredients. The active ingredient of the product consists of any of the...
PPCPs IN THE ENVIRONMENT: AN OVERVIEW OF THE ...
Pharmaceuticals and personal care products (PPCPs) comprise a large,diverse array of contaminants that can enter the environment from the combined activities, actions, and behaviors of multitudes of individualsas well as from veterinary and agricultural use (http://epa.gov/nerlesd1/chemistry/pharma/).Excretion, bathing, and disposal of leftover medications are the three primary routes of release from human activities (http://epa.gov/nerlesd1/chemistry/pharma/images/drawing.pdf). As trace environmentalc ontaminants in waters, sediments, and sewage sludge,they are largely unregulated in the U.S. The concentrations of individual active ingredients in environmental samples such as surface waters often range from parts-per-billion to parts-per-trillion - micrograms to nanograms per liter. Multiple active ingredients and their degradates, however, frequently occur together.The total, combined levels of these substances in a given environmental sample can be 1-2 orders of magnitude higher than their individual levels in waters, or upto the mg/kg level in treated sewage sludge (
PPCPS AS ENVIRONMENTAL CONTAMINANTS: AN ...
Pharmaceuticals and personal care products (PPCPs) comprise a large, diverse array of contaminants thatcan enter the environment from the combined activities, actions, and behaviors of multitudes of individualsas well as from veterinary and agricultural use (http://epa.gov/nerlesd1/chemistry/pharma/). Excretion, bathing, and disposal of leftover medications are the three primary routes of release from human activities(http://epa.gov/nerlesd1/chemistry/pharma/images/drawing.pdf). As trace environmental contaminants in waters,sediments, and sewage sludge, they are largely unregulated in the U.S. The concentrations of individual active ingredients in environmental samples such as surface waters often range from parts-per-billion to parts-per-trillion ¿ micrograms to nanograms per liter. Multiple active ingredients and their degradates, however, frequently occur together. The total, combined levels of these substances in a given environmental sample can be 1-2 orders of magnitude higher than their individual levels in waters, or up to the mg/kg level in treated sewage sludge (
21 CFR 341.40 - Permitted combinations of active ingredients.
Code of Federal Regulations, 2012 CFR
2012-04-01
... ingredients, or any aspirin and antacid combination provided that the product is labeled according to § 341.85... combination of acetaminophen with other analgesic-antipyretic active ingredients, or any aspirin and antacid... other analgesic-antipyretic active ingredients, or any aspirin and antacid combination provided that the...
21 CFR 341.40 - Permitted combinations of active ingredients.
Code of Federal Regulations, 2010 CFR
2010-04-01
... ingredients, or any aspirin and antacid combination provided that the product is labeled according to § 341.85... combination of acetaminophen with other analgesic-antipyretic active ingredients, or any aspirin and antacid... other analgesic-antipyretic active ingredients, or any aspirin and antacid combination provided that the...
21 CFR 341.40 - Permitted combinations of active ingredients.
Code of Federal Regulations, 2013 CFR
2013-04-01
... ingredients, or any aspirin and antacid combination provided that the product is labeled according to § 341.85... combination of acetaminophen with other analgesic-antipyretic active ingredients, or any aspirin and antacid... other analgesic-antipyretic active ingredients, or any aspirin and antacid combination provided that the...
21 CFR 341.40 - Permitted combinations of active ingredients.
Code of Federal Regulations, 2011 CFR
2011-04-01
... ingredients, or any aspirin and antacid combination provided that the product is labeled according to § 341.85... combination of acetaminophen with other analgesic-antipyretic active ingredients, or any aspirin and antacid... other analgesic-antipyretic active ingredients, or any aspirin and antacid combination provided that the...
21 CFR 341.40 - Permitted combinations of active ingredients.
Code of Federal Regulations, 2014 CFR
2014-04-01
... ingredients, or any aspirin and antacid combination provided that the product is labeled according to § 341.85... combination of acetaminophen with other analgesic-antipyretic active ingredients, or any aspirin and antacid... other analgesic-antipyretic active ingredients, or any aspirin and antacid combination provided that the...
21 CFR 357.810 - Active ingredients for deodorant drug products for internal use.
Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Active ingredients for deodorant drug products for... HUMAN USE Deodorant Drug Products for Internal Use § 357.810 Active ingredients for deodorant drug products for internal use. The active ingredient of the product consists of either of the following when...
21 CFR 357.810 - Active ingredients for deodorant drug products for internal use.
Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Active ingredients for deodorant drug products for... HUMAN USE Deodorant Drug Products for Internal Use § 357.810 Active ingredients for deodorant drug products for internal use. The active ingredient of the product consists of either of the following when...
21 CFR 357.810 - Active ingredients for deodorant drug products for internal use.
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Active ingredients for deodorant drug products for... HUMAN USE Deodorant Drug Products for Internal Use § 357.810 Active ingredients for deodorant drug products for internal use. The active ingredient of the product consists of either of the following when...
21 CFR 357.810 - Active ingredients for deodorant drug products for internal use.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Active ingredients for deodorant drug products for... HUMAN USE Deodorant Drug Products for Internal Use § 357.810 Active ingredients for deodorant drug products for internal use. The active ingredient of the product consists of either of the following when...
21 CFR 357.810 - Active ingredients for deodorant drug products for internal use.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Active ingredients for deodorant drug products for... HUMAN USE Deodorant Drug Products for Internal Use § 357.810 Active ingredients for deodorant drug products for internal use. The active ingredient of the product consists of either of the following when...
Code of Federal Regulations, 2013 CFR
2013-04-01
... control of dandruff and external analgesic active ingredients in § 358.720(b). The label states “dandruff...) Combinations of control of dandruff and external analgesic active ingredients in § 358.720(b). The labeling.... (1) Combinations of control of dandruff and external analgesic active ingredients in § 358.720(b...
Code of Federal Regulations, 2014 CFR
2014-04-01
... control of dandruff and external analgesic active ingredients in § 358.720(b). The label states “dandruff...) Combinations of control of dandruff and external analgesic active ingredients in § 358.720(b). The labeling.... (1) Combinations of control of dandruff and external analgesic active ingredients in § 358.720(b...
Code of Federal Regulations, 2012 CFR
2012-04-01
... control of dandruff and external analgesic active ingredients in § 358.720(b). The label states “dandruff...) Combinations of control of dandruff and external analgesic active ingredients in § 358.720(b). The labeling.... (1) Combinations of control of dandruff and external analgesic active ingredients in § 358.720(b...
USDA-ARS?s Scientific Manuscript database
The Dietary Supplement Ingredient Database (DSID) is a federal initiative to provide analytical validation of ingredients in dietary supplements. The first release on vitamins and minerals in adult MVMs is now available. Multiple lots of >100 representative adult MVMs were chemically analyzed for ...
Code of Federal Regulations, 2013 CFR
2013-07-01
... sec. 3(c)(7)-Products that contain a new active ingredient. 152.114 Section 152.114 Protection of...)(7)—Products that contain a new active ingredient. An application for registration of a pesticide containing an active ingredient not in any currently registered product may be conditionally approved for a...
Code of Federal Regulations, 2010 CFR
2010-07-01
... sec. 3(c)(7)-Products that contain a new active ingredient. 152.114 Section 152.114 Protection of...)(7)—Products that contain a new active ingredient. An application for registration of a pesticide containing an active ingredient not in any currently registered product may be conditionally approved for a...
Encapsulation of new active ingredients.
Onwulata, C I
2012-01-01
The organic construct consumed as food comes packaged in units that carry the active components and protect the entrapped active materials until delivered to targeted human organs. The packaging and delivery role is mimicked in the microencapsulation tools used to deliver active ingredients in processed foods. Microencapsulation efficiency is balanced against the need to access the entrapped nutrients in bioavailable forms. Encapsulated ingredients boosted with bioactive nutrients are intended for improved health and well-being and to prevent future health problems. Presently, active ingredients are delivered using new techniques, such as hydrogels, nanoemulsions, and nanoparticles. In the future, nutraceuticals and functional foods may be tailored to individual metabolic needs and tied to each person's genetic makeup. Bioactive ingredients provide health-enhancing nutrients and are protected through encapsulation processes that shield the active ingredients from deleterious environments.
The THz fingerprint spectra of the active ingredients of a TCM medicine: Herba Ephedrae
NASA Astrophysics Data System (ADS)
Ma, Shihua; Liu, Guifeng; Zhang, Peng; Song, Xiyu; Ji, Te; Wang, Wenfeng
2008-12-01
In this paper, THz-TDS has been used to measure the spectral properties of two active ingredients of Herba Ephedrae: ephedrine and pseudoephedrine, which exist in hydrochloride salts. The THz spectra of the sole-ingredient, twoingredient and three-ingredient compounds are studied. We obtained the finger-print spectra of the net active ingredients of the medicine, and also measured the mixtures of by two or three active ingredients at the different ratios. At the same time, theoretical analysis and quantitative analysis is applied to foretell the different THz spectra, identify the ingredients and infer the contents of principal components in samples. The THz spectroscopy is a potential and promising technique in evaluating and inspecting the quality of the drugs in the TCM field.
Ignoring Adjuvant Toxicity Falsifies the Safety Profile of Commercial Pesticides
Mesnage, Robin; Antoniou, Michael N.
2018-01-01
Commercial formulations of pesticides are invariably not single ingredients. Instead they are cocktails of chemicals, composed of a designated pesticidal “active principle” and “other ingredients,” with the latter collectively also known as “adjuvants.” These include surfactants, antifoaming agents, dyes, etc. Some adjuvants are added to influence the absorption and stability of the active principle and thus promote its pesticidal action. Currently, the health risk assessment of pesticides in the European Union and in the United States focuses almost exclusively on the stated active principle. Nonetheless, adjuvants can also be toxic in their own right with numerous negative health effects having been reported in humans and on the environment. Despite the known toxicity of adjuvants, they are regulated differently from active principles, with their toxic effects being generally ignored. Adjuvants are not subject to an acceptable daily intake, and they are not included in the health risk assessment of dietary exposures to pesticide residues. Here, we illustrate this gap in risk assessment by reference to glyphosate, the most used pesticide active ingredient. We also investigate the case of neonicotinoid insecticides, which are strongly suspected to be involved in bee and bumblebee colony collapse disorder. Authors of studies sometimes use the name of the active principle (for example glyphosate) when they are testing a commercial formulation containing multiple (active principle plus adjuvant) ingredients. This results in confusion in the scientific literature and within regulatory circles and leads to a misrepresentation of the safety profile of commercial pesticides. Urgent action is needed to lift the veil on the presence of adjuvants in food and human bodily fluids, as well as in the environment (such as in air, water, and soil) and to characterize their toxicological properties. This must be accompanied by regulatory precautionary measures to protect the environment and general human population from some toxic adjuvants that are currently missing from risk assessments. PMID:29404314
Zamengo, Luca; Frison, Giampietro; Bettin, Chiara; Sciarrone, Rocco
2014-08-17
New psychoactive substances (NPS), are now a large group of substances of abuse not yet completely controlled by international drug conventions, which may pose a public health threat. Anxiety, paranoia, hallucinations, seizures, hyperthermia and cardiotoxicity are some of the common adverse effects associated with these compounds. In this paper, three case reports taken from the archive of processed cases of the authors' laboratory are presented and discussed to stress the risks of possible adverse consequences for NPS users: in particular, (i) the risk deriving from the difficulty of predicting the actual consumed dose, due to variability of active ingredients concentration in consumed products, (ii) the risk deriving from the difficulty of predicting the actual active ingredients present in consumed products, as opposed to those claimed by the manufacturer, and (iii) the risk deriving from the difficulty of predicting the actual pharmacological and toxicological effects related to the simultaneous consumption of different psychoactive ingredients contained in single products, whose interactions are mostly unknown. Each of them individually provide a source of concern for possible serious health related consequences. However, they should be considered in conjunction with each others, with the worldwide availability of NPS through the web and also with the incessantly growing business derived from the manipulation and synthesis of new substances. The resulting scenario is that of a cultural challenge which demands a global approach from different fields of knowledge. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.
Testing of Candidate Icons to Identify Acetaminophen-Containing Medicines
Shiffman, Saul; Cotton, Helene; Jessurun, Christina; Sembower, Mark A.; Pype, Steve; Phillips, Jerry
2016-01-01
Adding icons on labels of acetaminophen-containing medicines could help users identify the active ingredient and avoid concomitant use of multiple medicines containing acetaminophen. We evaluated five icons for communication effectiveness. Adults (n = 300) were randomized to view a prescription container label or over-the-counter labels with either one or two icons. Participants saw two icon candidates, and reported their interpretation; experts judged whether these reflected critical confusions that might cause harm. Participants rated how effectively each icon communicated key messages. Icons based on abbreviations of “acetaminophen” (“Ac”, “Ace”, “Acm”) were rated less confusing and more effective in communicating the active ingredient than icons based on “APAP” or an abstract symbol. Icons did not result in critical confusion when seen on a readable medicine label. Icon implementation on prescription labels was more effective at communicating the warning against concomitant use than implementation on over-the-counter (OTC) labels. Adding an icon to a second location on OTC labels did not consistently enhance this communication, but reduced rated effectiveness of acetaminophen ingredient communication among participants with limited health literacy. The abbreviation-based icons seem most suitable for labeling acetaminophen-containing medications to enable users to identify acetaminophen-containing products. PMID:28970383
Yoshino, Atsushi; Polouliakh, Natalia; Meguro, Akira; Takeuchi, Masaki; Kawagoe, Tatsukata; Mizuki, Nobuhisa
2016-01-01
Components of fish roe possess antioxidant and antiaging activities, making them potentially very beneficial natural resources. Here, we investigated chum salmon eggs (CSEs) as a source of active ingredients, including vitamins, unsaturated fatty acids, and proteins. We incubated human dermal fibroblast cultures for 48 hours with high and low concentrations of CSE extracts and analyzed changes in gene expression. Cells treated with CSE extract showed concentration-dependent upregulation of collagen type I genes and of multiple antioxidative genes, including OXR1, TXNRD1, and PRDX family genes. We further conducted in silico phylogenetic footprinting analysis of promoter regions. These results suggested that transcription factors such as acute myeloid leukemia-1a and cyclic adenosine monophosphate response element-binding protein may be involved in the observed upregulation of antioxidative genes. Our results support the idea that CSEs are strong candidate sources of antioxidant materials and cosmeceutically effective ingredients.
78 FR 75343 - Pesticide Products; Registration Applications for New Active Ingredients
Federal Register 2010, 2011, 2012, 2013, 2014
2013-12-11
...; Registration Applications for New Active Ingredients AGENCY: Environmental Protection Agency (EPA). ACTION: Notice. SUMMARY: EPA has received several applications to register pesticide products containing active... products containing active ingredients not included in any currently registered pesticide products...
21 CFR 331.20 - Determination of percent contribution of active ingredients.
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Determination of percent contribution of active... Procedures § 331.20 Determination of percent contribution of active ingredients. To determine the percent contribution of an antacid active ingredient, place an accurately weighed amount of the antacid active...
21 CFR 331.20 - Determination of percent contribution of active ingredients.
Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Determination of percent contribution of active... Procedures § 331.20 Determination of percent contribution of active ingredients. To determine the percent contribution of an antacid active ingredient, place an accurately weighed amount of the antacid active...
21 CFR 331.20 - Determination of percent contribution of active ingredients.
Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Determination of percent contribution of active... Procedures § 331.20 Determination of percent contribution of active ingredients. To determine the percent contribution of an antacid active ingredient, place an accurately weighed amount of the antacid active...
21 CFR 331.20 - Determination of percent contribution of active ingredients.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Determination of percent contribution of active... Procedures § 331.20 Determination of percent contribution of active ingredients. To determine the percent contribution of an antacid active ingredient, place an accurately weighed amount of the antacid active...
Liu, Yi; Liu, Ping; Lin, Lu; Zhao, Yueqin; Zhong, Wenjuan; Wu, Lunjie; Zhou, Zhemin; Sun, Weifeng
2016-09-01
The maturation mechanism of nitrile hydratase (NHase) of Pseudomonas putida NRRL-18668 was discovered and named as "self-subunit swapping." Since the NHase of Bordetella petrii DSM 12804 is similar to that of P. putida, the NHase maturation of B. petrii is proposed to be the same as that of P. putida. However, there is no further information on the application of NHase according to these findings. We successfully rapidly purified NHase and its activator through affinity his tag, and found that the cell extracts of NHase possessed multiple types of protein ingredients including α, β, α2β2, and α(P14K)2 who were in a state of chemical equilibrium. Furthermore, the activity was significantly enhanced through adding extra α(P14K)2 to the cell extracts of NHase according to the chemical equilibrium. Our findings are useful for the activity enhancement of multiple-subunit enzyme and for the first time significantly increased the NHase activity according to the chemical equilibrium.
78 FR 10167 - Pesticide Products; Registration Applications for a New Active Ingredient
Federal Register 2010, 2011, 2012, 2013, 2014
2013-02-13
...; Registration Applications for a New Active Ingredient AGENCY: Environmental Protection Agency (EPA). ACTION: Notice. SUMMARY: EPA has received applications to register pesticide products containing an active... applications to register pesticide products containing an active ingredient not included in any currently...
An accurate and precise representation of drug ingredients.
Hanna, Josh; Bian, Jiang; Hogan, William R
2016-01-01
In previous work, we built the Drug Ontology (DrOn) to support comparative effectiveness research use cases. Here, we have updated our representation of ingredients to include both active ingredients (and their strengths) and excipients. Our update had three primary lines of work: 1) analysing and extracting excipients, 2) analysing and extracting strength information for active ingredients, and 3) representing the binding of active ingredients to cytochrome P450 isoenzymes as substrates and inhibitors of those enzymes. To properly differentiate between excipients and active ingredients, we conducted an ontological analysis of the roles that various ingredients, including excipients, have in drug products. We used the value specification model of the Ontology for Biomedical Investigations to represent strengths of active ingredients and then analyzed RxNorm to extract excipient and strength information and modeled them according to the results of our analysis. We also analyzed and defined dispositions of molecules used in aggregate as active ingredients to bind cytochrome P450 isoenzymes. Our analysis of excipients led to 17 new classes representing the various roles that excipients can bear. We then extracted excipients from RxNorm and added them to DrOn for branded drugs. We found excipients for 5,743 branded drugs, covering ~27% of the 21,191 branded drugs in DrOn. Our analysis of active ingredients resulted in another new class, active ingredient role. We also extracted strengths for all types of tablets, capsules, and caplets, resulting in strengths for 5,782 drug forms, covering ~41% of the 14,035 total drug forms and accounting for ~97 % of the 5,970 tablets, capsules, and caplets in DrOn. We represented binding-as-substrate and binding-as-inhibitor dispositions to two cytochrome P450 (CYP) isoenzymes (CYP2C19 and CYP2D6) and linked these dispositions to 65 compounds. It is now possible to query DrOn automatically for all drug products that contain active ingredients whose molecular grains inhibit or are metabolized by a particular CYP isoenzyme. DrOn is open source and is available at http://purl.obolibrary.org/obo/dron.owl.
21 CFR 212.50 - What production and process controls must I have?
Code of Federal Regulations, 2011 CFR
2011-04-01
... containers, closures, and packaging materials, including a specimen or copy of each label and all other... radioactivity or other measurement of each active pharmaceutical ingredient and each inactive ingredient per... active pharmaceutical ingredient and each inactive ingredient per batch or per unit of radioactivity or...
21 CFR 332.15 - Combination with non-antiflatulent active ingredients.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Combination with non-antiflatulent active... SERVICES (CONTINUED) DRUGS FOR HUMAN USE ANTIFLATULENT PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 332.15 Combination with non-antiflatulent active ingredients. An antiflatulent may contain any...
21 CFR 346.22 - Permitted combinations of anorectal active ingredients.
Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Permitted combinations of anorectal active... SERVICES (CONTINUED) DRUGS FOR HUMAN USE ANORECTAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 346.22 Permitted combinations of anorectal active ingredients. (a) Any two, three, or four...
21 CFR 332.15 - Combination with non-antiflatulent active ingredients.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Combination with non-antiflatulent active... SERVICES (CONTINUED) DRUGS FOR HUMAN USE ANTIFLATULENT PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 332.15 Combination with non-antiflatulent active ingredients. An antiflatulent may contain any...
21 CFR 333.320 - Permitted combinations of active ingredients.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Permitted combinations of active ingredients. 333... Topical Acne Drug Products § 333.320 Permitted combinations of active ingredients. (a) Resorcinol... of the user, the revised text is set forth as follows: § 333.320 Permitted combinations of active...
21 CFR 332.15 - Combination with non-antiflatulent active ingredients.
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Combination with non-antiflatulent active... SERVICES (CONTINUED) DRUGS FOR HUMAN USE ANTIFLATULENT PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 332.15 Combination with non-antiflatulent active ingredients. An antiflatulent may contain any...
21 CFR 332.15 - Combination with non-antiflatulent active ingredients.
Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Combination with non-antiflatulent active... SERVICES (CONTINUED) DRUGS FOR HUMAN USE ANTIFLATULENT PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 332.15 Combination with non-antiflatulent active ingredients. An antiflatulent may contain any...
21 CFR 346.22 - Permitted combinations of anorectal active ingredients.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Permitted combinations of anorectal active... SERVICES (CONTINUED) DRUGS FOR HUMAN USE ANORECTAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 346.22 Permitted combinations of anorectal active ingredients. (a) Any two, three, or four...
21 CFR 332.15 - Combination with non-antiflatulent active ingredients.
Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Combination with non-antiflatulent active... SERVICES (CONTINUED) DRUGS FOR HUMAN USE ANTIFLATULENT PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 332.15 Combination with non-antiflatulent active ingredients. An antiflatulent may contain any...
21 CFR 346.22 - Permitted combinations of anorectal active ingredients.
Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Permitted combinations of anorectal active... SERVICES (CONTINUED) DRUGS FOR HUMAN USE ANORECTAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 346.22 Permitted combinations of anorectal active ingredients. (a) Any two, three, or four...
Zhou, Chao; Liu, LiJuan; Zhuang, Jing; Wei, JunYu; Zhang, TingTing; Gao, ChunDi; Liu, Cun; Li, HuaYao; Si, HongZong; Sun, ChangGang
2018-06-23
BACKGROUND The method of multiple targets overall control is increasingly used to predict the main active ingredient and potential target group of Chinese traditional medicines and to determine the mechanisms involved in their curative effects. Qingdai is the main traditional Chinese medicine used in the treatment of chronic myelogenous leukemia (CML), but the complex active ingredients and antitumor targets in treatment of CML have not been clearly defined in previous studies. MATERIAL AND METHODS We constructed a protein-protein interaction network diagram of CML with 638 nodes (proteins) and 1830 edges, based on the biological function of chronic myelocytic leukemia by use of Cytoscape, and we determined 19 key gene nodes in the CML molecule by network topological properties analysis in a data bank. Then, we used the Surflex-dock plugin in SYBYL7.3 docking and acquired the protein crystal structures of key genes involved in CML from the chemical composition of the traditional Chinese medicine Qingdai with key proteins in CML networks. RESULTS According to the score and the spatial structure, the pharmacodynamically active ingredients of Qingdai are Isdirubin, Isoindigo, N-phenyl-2-naphthylamine, and Isatin, among which Isdirubin is the most important. We further screened the most effective activity key protein structures of CML to find the best pharmacodynamically active ingredients of Qingdai, according to the binding interactions of the inhibitors at the catalytic site performed in best docking combinations. CONCLUSIONS The results suggest that Isdirubin plays a role in resistance to CML by altering the expressions of PIK3CA, MYC, JAK2, and TP53 target proteins. Network pharmacology and molecular docking technology can be used to search for possible reactive molecules in traditional chinese medicines (TCM) and to elucidate their molecular mechanisms.
Zhang, Yiqian; Yu, Jiahui; Zhang, Wen; Wang, Yuewei; He, Yi; Zhou, Shuiping; Fan, Guanwei; Yang, Hua; Zhu, Yan; Li, Ping
2018-06-12
Qishen Yiqi is a widely used Chinese herbal medicine formula with "qi invigorating and blood activating" property. Its dripping pill preparation (QSYQ) is a commercial herbal medicine approved by the China Food and Drug Administration (CFDA) in 2003 and is extensively used clinically to treat cardiovascular diseases, such as ischemic heart failure and angina pectoris, as well as for the secondary prevention of myocardial infarction. However, the bioactive ingredients of QSYQ remain unclear. As QSYQ is a compound herbal formula, it is of great importance to elucidate its pharmacologically active ingredients and underlying synergetic effects. This experimental study was conducted to comprehensively determine the combinatorial bioactive ingredients (CBIs) in QSYQ and to elucidate their potential synergetic effects. The established strategy may shed new light on how to rapidly determine CBIs in complex herbal formulas with holistic properties. An integrated evidence-based targeting strategy was introduced and validated to determine CBIs in QSYQ. The strategy included the following steps: (1) Chemical ingredients in QSYQ were analyzed via UPLC-Q-TOF/MS in the negative and positive modes and were identified by comparison with standard compounds and previously reported data. Their potential therapeutic activities were predicted based on the ChEMBL database to preliminarily search for candidate bioactive ingredients, and their combination was defined as the CBIs. (2) The CBIs were directly trapped and prepared from QSYQ with a two-dimensional chromatographic separation system, and the remaining part was defined as the rest ingredients (RIs). (3) As animal and cell models, left anterior descending coronary artery ligation (LAD)-induced heart failure in rats and hypoxia-induced cardiac myocyte injury in H9c2 cells were applied to compare the potency of QSYQ, CBIs and RIs. (4) The synergetic effects on cardiac myocyte protection of multiple ingredients in CBIs were examined in this cell model. (1) Forty-three ingredients in QSYQ were identified via UPLC-Q-TOF/MS. Based on evidence-based screening using the ChEMBL database, 24 ingredients were predicted to be bioactive ingredients, and their combination was considered the CBIs. (2) The CBIs and RIs were successfully prepared according to a two-dimensional chromatographic system. The CBIs were directly trapped and knocked out from QSYQ by hydrophilic interaction liquid chromatography coupled with reverse-phase liquid chromatography. The remaining part was used as RIs. (3) The results from pharmacological evaluation revealed that CBIs and QSYQ, but not RIs, significantly prevented myocardium injury; improved the ejection fraction (EF) and fractional shortening (FS); decreased the release of cardiac enzymes, including CK, CK-MB, and LDH; alleviated mitochondrial dysfunction; and protected the cell nucleus number and mitochondrial mass. Furthermore, QSYQ and CBIs possessed similar potency. (4) In hypoxia-stimulated H9c2 cells, CBIs showed far greater potency regarding the protection of cardiac myocyte injury than the individual ingredients in QSYQ, exhibiting obvious synergetic effects. An integrated evidence-based targeting strategy was successfully established and validated to determine CBIs from QSYQ with excellent efficiency. Importantly, the holistic property of QSYQ was retained in the CBIs. Hence, this study may shed new light on how to rapidly reveal combinatorial bioactive ingredients from complex prescriptions and will be greatly helpful in the establishment of an appropriate approach to quality control for herbal medicines. Copyright © 2018 Elsevier B.V. All rights reserved.
21 CFR 347.60 - Labeling of permitted combinations of active ingredients.
Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Labeling of permitted combinations of active... Labeling § 347.60 Labeling of permitted combinations of active ingredients. The statement of identity.... (1) Combinations of skin protectant and external analgesic active ingredients in § 347.20(b). In...
21 CFR 347.60 - Labeling of permitted combinations of active ingredients.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Labeling of permitted combinations of active... Labeling § 347.60 Labeling of permitted combinations of active ingredients. The statement of identity.... (1) Combinations of skin protectant and external analgesic active ingredients in § 347.20(b). In...
21 CFR 347.60 - Labeling of permitted combinations of active ingredients.
Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Labeling of permitted combinations of active... Labeling § 347.60 Labeling of permitted combinations of active ingredients. The statement of identity.... (1) Combinations of skin protectant and external analgesic active ingredients in § 347.20(b). In...
Hu, Fangdi; An, Jing; Li, Wen; Zhang, Zijia; Chen, Wenxia; Wang, Changhong; Wang, Zhengtao
2015-07-01
Eucommiae cortex (EC), the bark of Eucommia ulmoides Oliv., has been traditionally used to treat many diseases in China for more than 2000 years. The pharmacological effects are primarily attributed to the presence of lignans, iridoids and phenolics, which are main active ingredients in EC. First, to investigate the active ingredients that can be absorbed into the rat plasma according to which ingredients exhibit significant correlation of drug concentration-time curve. Second, to establish an efficient ultra-performance liquid chromatography/tandem mass spectrometry (UPLC-MS/MS) method for simultaneous determination of ingredients absorbed in rat plasma. Finally, to investigate gender effect on the pharmacokinetics of the ingredients absorbed in male and female rats plasma after oral administration with EC extract. 18 ingredients from EC were detected by UPLC-MS/MS, 9 out of 18 ingredients were absorbed into rat plasma. And 5 ingredients exhibit significant correlation of drug concentration-time curve. They were pinoresinol di-O-β-d-glucopyranoside (PDG), geniposide (GE), geniposidic acid (GA), aucubin (AN) and chlorogenic acid (CA). The analytes were extracted from rat plasma via a simple protein precipitation procedure and osalmid was used as the internal standard. Chromatographic separation was achieved on a Waters ACQUITY HSS T3 column (2.1mm×100mm, 1.8μm) using a gradient elution program with acetonitrile and 0.1% formic acid water as the mobile phase, with a flow rate of 0.3mLmin(-1). The detection was performed on a triple-quadrupole tandem mass spectrometer by multiple reactions monitoring (MRM) mode in a positive ion mode via electrospray ionization (ESI). The transition monitored were /z 683.00[M+H](+)→235.10 for PDG, / z 389.00[M+H](+)→208.80 for GE, m/z 375.00[M+H](+)→194.79 for GA, m/z 364.00[M+NH4](+)→148.81 for AN, m/z 355.10[M+H](+)→162.84 for CA and m/z 230.03[M+H](+)→120.77 for internal standard. The developed method showed good linearity over a wide concentration range, the lower limits of quantification and higher accuracy and precision for determination of the 5 analytes. Then the method was applied to study the pharmacokinetics in rats, and the results indicated that there were significant differences in pharmacokinetic parameters of the analytes between the male and female rats, and absorptions of these analytes in male group were all significantly higher than those in female group. This study established an efficient, sensitive and selective UPLC-MS/MS method for simultaneous determination of the five ingredients in rat plasma, and it could be successfully applied to the comparative pharmacokinetic studies in male and female rats after oral administration with EC extract. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.
Code of Federal Regulations, 2010 CFR
2010-07-01
... material containing an active ingredient: (1) Which contains no inert ingredient, other than one used for.... The following terms are defined for the purposes of this subpart: (a) Active ingredient means any.... (c) Formulation means (1) The process of mixing, blending, or dilution of one or more active...
Zhao, Fangli; Guochun, Li; Yang, Yanhua; Shi, Le; Xu, Li; Yin, Lian
2015-06-20
Modified Simiaowan (MSW) is a traditional Chinese medicine (TCM) formula and is widely used as a clinically medication formula for its efficiency in treating gouty diseases.To predict the active ingredients in MSW and uncover the rationality of herb combinations of MSW. Three drug-target networks including the "candidate ingredient-target network" (cI-cT) that links the candidate ingredients and targets, the "core ingredient-target-pathway network" connecting core potential ingredients and targets through related pathways, and the "rationality of herb combinations of MSW network", which was derived from the cI-cT network, were developed to dissect the active ingredients in MSW and relationship between ingredients in herb combinations and their targets for gouty diseases. On the other hand, herbal ingredients comparisons were also conducted based on six physicochemical properties to investigate whether the herbs in MSW are similar in chemicals. Moreover, HUVEC viability and expression levels of ICAM-1 induced by monosodium urate (MSU) crystals were assessed to determine the activities of potential ingredients in MSW. Predicted by the core ingredient-target-pathway network, we collected 30 core ingredients in MSW and 25 inflammatory cytokines and uric acid synthetase or transporters, which are effective for gouty treatment through some related pathways. Experimental results also confirmed that those core ingredients could significantly increase HUVEC viability and attenuate the expression of ICAM-1, which supported the effectiveness of MSW in treating gouty diseases. Moreover, heat-clearing and dampness-eliminating herbs in MSW have similar physicochemical properties, which stimulate all the inflammatory and uric acid-lowing targets respectively, while the core drug and basic prescription in MSW stimulate the major and almost all the core targets, respectively. Our work successfully predicts the active ingredients in MSW and explains the cooperation between these ingredients and corresponding targets through related pathways for gouty diseases, and provides basis for an alternative approach to investigate the rationality of herb combinations of MSW on the network pharmacology level, which might be beneficial to drug development and applications. Copyright © 2015. Published by Elsevier Ireland Ltd.
Knaak, Stephanie; Modgill, Geeta; Patten, Scott B
2014-10-01
As part of its ongoing effort to combat stigma against mental illness among health care providers, the Mental Health Commission of Canada partnered with organizations conducting anti-stigma interventions. Our objective was to evaluate program effectiveness and to better understand what makes some programs more effective than others. Our paper reports the elements of these programs found to be most strongly associated with favourable outcomes. Our study employed a multi-phased, mixed-methods design. First, a grounded theory qualitative study was undertaken to identify key program elements. Next, each program (n = 22) was coded according to the presence or absence of the identified key program ingredients. Then, random-effects, meta-regression modelling was used to examine the association between program outcomes and the key ingredients. The qualitative analysis led to a 6-ingredient model of key program elements. Results of the quantitative analysis showed that programs that included all 6 of these ingredients performed significantly better than those that did not. Individual analyses of each of the 6 ingredients showed that including multiple forms of social contact and emphasizing recovery were characteristics of the most effective programs. The results provide a validation of a 6-ingredient model of key program elements for anti-stigma programming for health care providers. Emphasizing recovery and including multiple types of social contact are of particular importance for maximizing the effectiveness of anti-stigma programs for health care providers.
77 FR 72342 - Notice of Receipt of Pesticide Products; Registration Applications
Federal Register 2010, 2011, 2012, 2013, 2014
2012-12-05
...: EPA has received applications to register pesticide products containing an active ingredient not... applications to register pesticide products containing an active ingredient not included in any currently... containing an active ingredient not included in any currently registered products: 1. EPA File Symbol: 43808...
Hao, Jing; Rodriguez-Monguio, Rosa; Seoane-Vazquez, Enrique
2015-01-01
Fixed-dose combinations (FDC) contain two or more active ingredients. The effective patent and exclusivity life of FDC compared to single active ingredient has not been assessed. Trends in FDA approved FDC in the period 1980-2012 and time lag between approval of FDC and single active ingredients in the combination were assessed, and the effective patent and exclusivity life of FDC was compared with their single active ingredients. New molecular entities (NMEs), new therapeutic biologics license applications (BLAs) and FDC data were collected from the FDA Orange Book and Drugs@FDA. Analysis included FDC containing one or more NMEs or BLAs at first FDA approval (NMEs-FDC) and only already marketed drugs (Non-NMEs-FDC). Descriptive, Kruskal-Wallis and Wilcoxon Rank Sum analyses were performed. During the study period, the FDA approved 28 NMEs-FDC (3.5% of NMEs) and 117 non-NMEs-FDC. FDC approvals increased from 12 in the 1980s to 59 in the 2000s. Non-NMEs-FDC entered the market at a median of 5.43 years (interquartile range 1.74, 10.31) after first FDA approval of single active ingredients in the combination. The Non-NMEs-FDC entered the market at a median of 2.33 years (-7.55, 2.39) before approval of generic single active ingredient. Non-NME-FDC added a median of 9.70 (2.75, 16.24) years to the patent and exclusivity life of the single active ingredients in the combination. FDC approvals significantly increased over the last twenty years. Pharmaceutical companies market FDC drugs shortly before the generic versions of the single ingredients enter the market extending the patent and exclusivity life of drugs included in the combination.
Systems-level mechanisms of action of Panax ginseng: a network pharmacological approach.
Park, Sa-Yoon; Park, Ji-Hun; Kim, Hyo-Su; Lee, Choong-Yeol; Lee, Hae-Jeung; Kang, Ki Sung; Kim, Chang-Eop
2018-01-01
Panax ginseng has been used since ancient times based on the traditional Asian medicine theory and clinical experiences, and currently, is one of the most popular herbs in the world. To date, most of the studies concerning P. ginseng have focused on specific mechanisms of action of individual constituents. However, in spite of many studies on the molecular mechanisms of P. ginseng , it still remains unclear how multiple active ingredients of P. ginseng interact with multiple targets simultaneously, giving the multidimensional effects on various conditions and diseases. In order to decipher the systems-level mechanism of multiple ingredients of P. ginseng , a novel approach is needed beyond conventional reductive analysis. We aim to review the systems-level mechanism of P. ginseng by adopting novel analytical framework-network pharmacology. Here, we constructed a compound-target network of P. ginseng using experimentally validated and machine learning-based prediction results. The targets of the network were analyzed in terms of related biological process, pathways, and diseases. The majority of targets were found to be related with primary metabolic process, signal transduction, nitrogen compound metabolic process, blood circulation, immune system process, cell-cell signaling, biosynthetic process, and neurological system process. In pathway enrichment analysis of targets, mainly the terms related with neural activity showed significant enrichment and formed a cluster. Finally, relative degrees analysis for the target-disease association of P. ginseng revealed several categories of related diseases, including respiratory, psychiatric, and cardiovascular diseases.
Metalloporphyrins and their uses as radiosensitizers for radiation therapy
Miura, Michiko; Slatkin, Daniel N.
2004-07-06
The present invention covers radiosensitizers containing as an active ingredient halogenated derivatives of boronated porphyrins containing multiple carborane cages having the structure ##STR1## which selectively accumulate in neoplastic tissue within the irradiation volume and thus can be used in cancer therapies including, but not limited to, boron neutron--capture therapy and photodynamic therapy. The present invention also covers methods for using these radiosensitizers in tumor imaging and cancer treatment.
21 CFR 333.320 - Permitted combinations of active ingredients.
Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Permitted combinations of active ingredients. 333.320 Section 333.320 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... Topical Acne Drug Products § 333.320 Permitted combinations of active ingredients. (a) Resorcinol...
21 CFR 333.320 - Permitted combinations of active ingredients.
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Permitted combinations of active ingredients. 333.320 Section 333.320 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... Topical Acne Drug Products § 333.320 Permitted combinations of active ingredients. (a) Resorcinol...
21 CFR 333.320 - Permitted combinations of active ingredients.
Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Permitted combinations of active ingredients. 333.320 Section 333.320 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... Topical Acne Drug Products § 333.320 Permitted combinations of active ingredients. (a) Resorcinol...
21 CFR 333.320 - Permitted combinations of active ingredients.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Permitted combinations of active ingredients. 333.320 Section 333.320 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... Topical Acne Drug Products § 333.320 Permitted combinations of active ingredients. (a) Resorcinol...
40 CFR 152.81 - Applicability.
Code of Federal Regulations, 2010 CFR
2010-07-01
...) Each application for registration of a new product; (2) Each application for an amendment of a... more of the active ingredients used in the product, if the new source of the active ingredient is a...): (i) An increase or decrease in the percentage in the product of one or more of its active ingredients...
21 CFR 340.10 - Stimulant active ingredient.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Stimulant active ingredient. 340.10 Section 340.10 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE STIMULANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredient § 340.10...
21 CFR 347.12 - Astringent active ingredients.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Astringent active ingredients. 347.12 Section 347.12 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE SKIN PROTECTANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients...
Bi, Xiaolin; Du, Qiu; Di, Liuqing
2010-02-01
Oral drug bioavailability depends on gastrointestinal absorption, intestinal transporters and metabolism enzymes are the important factors in drug gastrointestinal absorption and they can also be induced or inhibited by the active ingredients of Chinese materia medica. This article presents important application of intestinal transporters and metabolism enzymes on gastrointestinal disposal of the active ingredients of Chinese materia medica, and points out the importance of research on transport and metabolism of the active ingredients of Chinese materia medica in Chinese extract and Chinese medicinal formulae.
21 CFR 343.22 - Permitted combinations of active ingredients for cardiovascular-rheumatologic use.
Code of Federal Regulations, 2012 CFR
2012-04-01
... active ingredients for cardiovascular-rheumatologic use. Combinations containing aspirin must meet the... permitted: Aspirin identified in §§ 343.12 and 343.13 may be combined with any antacid ingredient identified...
21 CFR 343.22 - Permitted combinations of active ingredients for cardiovascular-rheumatologic use.
Code of Federal Regulations, 2011 CFR
2011-04-01
... active ingredients for cardiovascular-rheumatologic use. Combinations containing aspirin must meet the... permitted: Aspirin identified in §§ 343.12 and 343.13 may be combined with any antacid ingredient identified...
21 CFR 343.22 - Permitted combinations of active ingredients for cardiovascular-rheumatologic use.
Code of Federal Regulations, 2014 CFR
2014-04-01
... active ingredients for cardiovascular-rheumatologic use. Combinations containing aspirin must meet the... permitted: Aspirin identified in §§ 343.12 and 343.13 may be combined with any antacid ingredient identified...
21 CFR 343.22 - Permitted combinations of active ingredients for cardiovascular-rheumatologic use.
Code of Federal Regulations, 2013 CFR
2013-04-01
... active ingredients for cardiovascular-rheumatologic use. Combinations containing aspirin must meet the... permitted: Aspirin identified in §§ 343.12 and 343.13 may be combined with any antacid ingredient identified...
21 CFR 343.22 - Permitted combinations of active ingredients for cardiovascular-rheumatologic use.
Code of Federal Regulations, 2010 CFR
2010-04-01
... active ingredients for cardiovascular-rheumatologic use. Combinations containing aspirin must meet the... permitted: Aspirin identified in §§ 343.12 and 343.13 may be combined with any antacid ingredient identified...
Pesticide Risk Indicators: Unidentified Inert Ingredients Compromise Their Integrity and Utility
NASA Astrophysics Data System (ADS)
Surgan, Michael; Condon, Madison; Cox, Caroline
2010-04-01
Pesticide Risk Indicators (PRIs) are widely used to evaluate and compare the potential health and environmental risks of pesticide use and to guide pest control policies and practices. They are applied to agricultural, landscape and structural pest management by governmental agencies, private institutions and individuals. PRIs typically assess only the potential risks associated with the active ingredients because, with few exceptions, pesticide manufacturers disclose only the identity of the active ingredients which generally comprise only a minor portion of pesticide products. We show that when inert ingredients are identified and assessed by the same process as the active ingredient, the product specific risk can be much greater than that calculated for the active ingredient alone. To maintain transparency in risk assessment, all those who develop and apply PRIs or make decisions based on their output, should clearly disclose and discuss the limitations of the method.
[Induction of NAD(P)H: quinone reductase by anticarcinogenic ingredients of tea].
Qi, L; Han, C
1998-09-30
By assaying the activity of NAD(P)H: quinone reductase (QR) in Hep G2 cells exposed to inducing agents, a variety of ingredients in tea, we compared their abilities on inducing QR and preventing cancer. The results showed that tea polyphenols, tea pigments and mixed tea were all able to induce the activity of QR significantly. The single-component ingredients of tea polyphenols and tea pigments, including thearubigens, EGCG and ECG, also enhanced the activity of QR. But EGC, EC, theaflavins, tea polysaccharide and tea caffeine, showed no apparent induction of QR. We found that among those tea ingredients studied, the multi-component ingredients were more effective than the single-component ones. So we thought that the abilities of antioxidation and cancer prevention of tea depended on the combined effects of several kinds of active ingredients, which mainly include tea polyphenols and tea pigments.
40 CFR 161.390 - Reentry protection data requirements.
Code of Federal Regulations, 2011 CFR
2011-07-01
... met: (i)(A) The acute dermal toxicity of the technical grade of active ingredient is less than 200 mg/kg (body weight); or (B) The acute inhalation toxicity of the technical grade of active ingredient is... of active ingredient is less than 50 mg/kg (body weight); or (D) Neurotoxic, teratogenic, or...
40 CFR 161.390 - Reentry protection data requirements.
Code of Federal Regulations, 2013 CFR
2013-07-01
... met: (i)(A) The acute dermal toxicity of the technical grade of active ingredient is less than 200 mg/kg (body weight); or (B) The acute inhalation toxicity of the technical grade of active ingredient is... of active ingredient is less than 50 mg/kg (body weight); or (D) Neurotoxic, teratogenic, or...
40 CFR 161.390 - Reentry protection data requirements.
Code of Federal Regulations, 2012 CFR
2012-07-01
... met: (i)(A) The acute dermal toxicity of the technical grade of active ingredient is less than 200 mg/kg (body weight); or (B) The acute inhalation toxicity of the technical grade of active ingredient is... of active ingredient is less than 50 mg/kg (body weight); or (D) Neurotoxic, teratogenic, or...
Using Indices of Fidelity to Intervention Core Components to Identify Program Active Ingredients
ERIC Educational Resources Information Center
Abry, Tashia; Hulleman, Chris S.; Rimm-Kaufman, Sara E.
2015-01-01
Identifying the active ingredients of an intervention--intervention-specific components serving as key levers of change--is crucial for unpacking the intervention black box. Measures of intervention fidelity can be used to identify specific active ingredients, yet such applications are rare. We illustrate how fidelity measures can be used to…
21 CFR 352.60 - Labeling of permitted combinations of active ingredients.
Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Labeling of permitted combinations of active ingredients. 352.60 Section 352.60 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... INDEFINITELY] Labeling § 352.60 Labeling of permitted combinations of active ingredients. Statements of...
21 CFR 349.79 - Labeling of permitted combinations of active ingredients.
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Labeling of permitted combinations of active ingredients. 349.79 Section 349.79 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... § 349.79 Labeling of permitted combinations of active ingredients. Statements of identity, indications...
21 CFR 352.60 - Labeling of permitted combinations of active ingredients.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Labeling of permitted combinations of active ingredients. 352.60 Section 352.60 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... INDEFINITELY] Labeling § 352.60 Labeling of permitted combinations of active ingredients. Statements of...
21 CFR 346.52 - Labeling of permitted combinations of anorectal active ingredients.
Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Labeling of permitted combinations of anorectal active ingredients. 346.52 Section 346.52 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF... HUMAN USE Labeling § 346.52 Labeling of permitted combinations of anorectal active ingredients...
21 CFR 349.79 - Labeling of permitted combinations of active ingredients.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Labeling of permitted combinations of active ingredients. 349.79 Section 349.79 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... § 349.79 Labeling of permitted combinations of active ingredients. Statements of identity, indications...
21 CFR 349.79 - Labeling of permitted combinations of active ingredients.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Labeling of permitted combinations of active ingredients. 349.79 Section 349.79 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... § 349.79 Labeling of permitted combinations of active ingredients. Statements of identity, indications...
21 CFR 352.60 - Labeling of permitted combinations of active ingredients.
Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Labeling of permitted combinations of active ingredients. 352.60 Section 352.60 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... INDEFINITELY] Labeling § 352.60 Labeling of permitted combinations of active ingredients. Statements of...
21 CFR 346.52 - Labeling of permitted combinations of anorectal active ingredients.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Labeling of permitted combinations of anorectal active ingredients. 346.52 Section 346.52 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF... HUMAN USE Labeling § 346.52 Labeling of permitted combinations of anorectal active ingredients...
21 CFR 349.79 - Labeling of permitted combinations of active ingredients.
Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Labeling of permitted combinations of active ingredients. 349.79 Section 349.79 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... § 349.79 Labeling of permitted combinations of active ingredients. Statements of identity, indications...
21 CFR 346.52 - Labeling of permitted combinations of anorectal active ingredients.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Labeling of permitted combinations of anorectal active ingredients. 346.52 Section 346.52 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF... HUMAN USE Labeling § 346.52 Labeling of permitted combinations of anorectal active ingredients...
21 CFR 346.52 - Labeling of permitted combinations of anorectal active ingredients.
Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Labeling of permitted combinations of anorectal active ingredients. 346.52 Section 346.52 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF... HUMAN USE Labeling § 346.52 Labeling of permitted combinations of anorectal active ingredients...
21 CFR 346.52 - Labeling of permitted combinations of anorectal active ingredients.
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Labeling of permitted combinations of anorectal active ingredients. 346.52 Section 346.52 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF... HUMAN USE Labeling § 346.52 Labeling of permitted combinations of anorectal active ingredients...
21 CFR 349.79 - Labeling of permitted combinations of active ingredients.
Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Labeling of permitted combinations of active ingredients. 349.79 Section 349.79 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... § 349.79 Labeling of permitted combinations of active ingredients. Statements of identity, indications...
21 CFR 358.510 - Corn and callus remover active ingredients.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Corn and callus remover active ingredients. 358.510 Section 358.510 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... USE Corn and Callus Remover Drug Products § 358.510 Corn and callus remover active ingredients. The...
37 CFR 1.710 - Patents subject to extension of the patent term.
Code of Federal Regulations, 2013 CFR
2013-07-01
... product as defined in paragraph (b) of this section, either alone or in combination with other ingredients... active ingredient of a new human drug, antibiotic drug, or human biological product (as those terms are... or ester of the active ingredient, as a single entity or in combination with another active...
37 CFR 1.710 - Patents subject to extension of the patent term.
Code of Federal Regulations, 2014 CFR
2014-07-01
... product as defined in paragraph (b) of this section, either alone or in combination with other ingredients... active ingredient of a new human drug, antibiotic drug, or human biological product (as those terms are... or ester of the active ingredient, as a single entity or in combination with another active...
37 CFR 1.710 - Patents subject to extension of the patent term.
Code of Federal Regulations, 2011 CFR
2011-07-01
... product as defined in paragraph (b) of this section, either alone or in combination with other ingredients... active ingredient of a new human drug, antibiotic drug, or human biological product (as those terms are... or ester of the active ingredient, as a single entity or in combination with another active...
37 CFR 1.710 - Patents subject to extension of the patent term.
Code of Federal Regulations, 2010 CFR
2010-07-01
... product as defined in paragraph (b) of this section, either alone or in combination with other ingredients... active ingredient of a new human drug, antibiotic drug, or human biological product (as those terms are... or ester of the active ingredient, as a single entity or in combination with another active...
37 CFR 1.710 - Patents subject to extension of the patent term.
Code of Federal Regulations, 2012 CFR
2012-07-01
... product as defined in paragraph (b) of this section, either alone or in combination with other ingredients... active ingredient of a new human drug, antibiotic drug, or human biological product (as those terms are... or ester of the active ingredient, as a single entity or in combination with another active...
NASA Astrophysics Data System (ADS)
Li, Xiao; Xu, Lingyi; Cui, Yuqian; Pang, Meixia; Wang, Fang; Qi, Jinghua
2017-12-01
Extraction and anti-bacteria effect of active ingredients of Cacumen Platycladi were studied in this paper. Extraction combined with ultrasonic was adopted. The optimum extraction condition was determined by single factor test; the anti-bacteria effect of active ingredients and minimum inhibitory concentration(MIC) were valued by Oxford-cup method. The results indicated that kaempferol was the active ingredients of Cacumen Platycladi whose optimum extraction condition for ethanol concentrations were sixty-five percent and twenty minutes with ultrasonic assisted extraction.; the active ingredients of Cacumen Platycladi had anti-bacteria effect on Staphylococcus, Proteus, Bacillus, Serratia and MIC was 0.5 g/mL,0.5 g/mL,0.0313 g/mL and 0.0625 g/mL. The active constituent of Cacumen Platycladi is kaempferol which has obvious anti-bacteria effect and can be used to prolong the shelf-life of Low-temperature meat products.
Correia, Roberta; Grace, Mary H; Esposito, Debora; Lila, Mary Ann
2017-11-15
Particulate colloidal aggregate food ingredients were prepared by complexing wheat flour, chickpea flour, coconut flour and soy protein isolate with aqueous wild blueberry pomace extracts, then spray drying, freeze drying, or vacuum oven drying to prepare dry, flour-like matrices. Physico-chemical attributes, phytochemical content and stability during storage were compared. Eighteen anthocyanins peaks were identified for samples. Spray dried matrices produced with soy protein isolate had the highest concentration of polyphenols (156.2mg GAE/g) and anthocyanins (13.4mg/g) and the most potent DPPH scavenging activity (714.1μmolesTE/g). Spray dried blueberry polyphenols complexed with protein were protected from degradation during 16weeks at 4°C and 20°C. Soy protein isolate more efficiently captured and stabilized wild blueberry pomace phytochemicals than other protein sources. Overall, spray drying the blueberry extracts complexed with protein proved to be an environment-friendly strategy to produce stable functional ingredients with multiple applications for the food industry. Copyright © 2017 Elsevier Ltd. All rights reserved.
Kim, Misook; Kim, Eunji; Kwak, Han Sub; Jeong, Yoonhwa
2014-10-01
We investigated total 26 ingredients of Saengshik which will be commercially produced as an anti-diabetic dietary supplement. Thirteen vegetables, nine cereals, three legumes and one seed were extracted with aqueous ethanol for 2 h at 60℃, and evaluated for their inhibitory effects against α-amylase and α-glucosidase and for total phenolic and flavonoid contents. All ingredients inhibited α-amylase activity except cabbage. Strong inhibitory activity of α-amylase was observed in leek, black rice, angelica and barley compared with acarbose as a positive control. Stronger inhibition of α-glucosidase activity was found in small water dropwort, radish leaves, sorghum and cabbage than acarbose. All Saengshik ingredients suppressed α-glucosidase activity in the range of 0.3-60.5%. Most ingredients contained total phenols which were in the range of 1.2-229.4 mg gallic acid equivalent/g dried extract. But, total phenolic contents were not observed in carrot, pumpkin and radish. All ingredients contained flavonoid in the range of 11.6-380.7 mg catechin equivalent/g dried extract. Our results demonstrate that Saengshik containing these ingredients would be an effective dietary supplement for diabetes.
Yoshino, Atsushi; Polouliakh, Natalia; Meguro, Akira; Takeuchi, Masaki; Kawagoe, Tatsukata; Mizuki, Nobuhisa
2016-01-01
Components of fish roe possess antioxidant and antiaging activities, making them potentially very beneficial natural resources. Here, we investigated chum salmon eggs (CSEs) as a source of active ingredients, including vitamins, unsaturated fatty acids, and proteins. We incubated human dermal fibroblast cultures for 48 hours with high and low concentrations of CSE extracts and analyzed changes in gene expression. Cells treated with CSE extract showed concentration-dependent upregulation of collagen type I genes and of multiple antioxidative genes, including OXR1, TXNRD1, and PRDX family genes. We further conducted in silico phylogenetic footprinting analysis of promoter regions. These results suggested that transcription factors such as acute myeloid leukemia-1a and cyclic adenosine monophosphate response element-binding protein may be involved in the observed upregulation of antioxidative genes. Our results support the idea that CSEs are strong candidate sources of antioxidant materials and cosmeceutically effective ingredients. PMID:27621603
Code of Federal Regulations, 2012 CFR
2012-07-01
... ingredients with one or more other active or inert ingredients, without an intended chemical reaction, to... technical grade cannot be isolated) by chemical reaction. (k) Technical grade of active ingredient means a... unreacted starting materials, side reaction products, contaminants, and degradation products. (e) Impurity...
van de Merwe, Jason P; Neale, Peta A; Melvin, Steven D; Leusch, Frederic D L
2018-06-01
Pesticides commonly used around households can contain additives of unknown concentrations and toxicity. Given the likelihood of these chemicals washing into urban waterways, it is important to understand the effects that these additives may have on aquatic organisms. The aim of this study was to compare the toxicity of commercially available household pesticides to that of the active ingredient(s) alone. The toxicity of five household pesticides (three herbicides and two insecticides) was investigated using a bacterial cytotoxicity bioassay and an algal photosynthesis bioassay. The commercial products were up to an order of magnitude more toxic than the active ingredient(s) alone. In addition, two commercial products with the same listed active ingredients in the same ratio had a 600× difference in potency. These results clearly demonstrate that additives in commercial formulations are significant contributors to the toxicity of household pesticides. The toxicity of pesticides in aquatic systems is therefore likely underestimated by conventional chemical monitoring and risk assessment when only the active ingredients are considered. Regulators and customers should require more clarity from pesticide manufacturers about the nature and concentrations of not only the active ingredients, but also additives used in commercial formulations. In addition, monitoring programmes and chemical risk assessments schemes should develop a structured approach to assessing the toxic effects of commercial formulations, including additives, rather than simply those of the listed active ingredients. Copyright © 2018. Published by Elsevier B.V.
40 CFR 180.1153 - Lepidopteran pheromones; exemption from the requirement of a tolerance.
Code of Federal Regulations, 2013 CFR
2013-07-01
... rate not to exceed 150 grams active ingredient/acre/year in accordance with good agricultural practices; and applied as a post-harvest treatment to stored food commodities at a rate not to exceed 3.5 grams active ingredient/1,000 ft2/year (equivalent to 150 grams active ingredient/acre/year) in accordance with...
40 CFR 180.1153 - Lepidopteran pheromones; exemption from the requirement of a tolerance.
Code of Federal Regulations, 2014 CFR
2014-07-01
... rate not to exceed 150 grams active ingredient/acre/year in accordance with good agricultural practices; and applied as a post-harvest treatment to stored food commodities at a rate not to exceed 3.5 grams active ingredient/1,000 ft2/year (equivalent to 150 grams active ingredient/acre/year) in accordance with...
40 CFR 180.1153 - Lepidopteran pheromones; exemption from the requirement of a tolerance.
Code of Federal Regulations, 2011 CFR
2011-07-01
... rate not to exceed 150 grams active ingredient/acre/year in accordance with good agricultural practices; and applied as a post-harvest treatment to stored food commodities at a rate not to exceed 3.5 grams active ingredient/1,000 ft2/year (equivalent to 150 grams active ingredient/acre/year) in accordance with...
40 CFR 180.1153 - Lepidopteran pheromones; exemption from the requirement of a tolerance.
Code of Federal Regulations, 2012 CFR
2012-07-01
... rate not to exceed 150 grams active ingredient/acre/year in accordance with good agricultural practices; and applied as a post-harvest treatment to stored food commodities at a rate not to exceed 3.5 grams active ingredient/1,000 ft2/year (equivalent to 150 grams active ingredient/acre/year) in accordance with...
40 CFR 180.1153 - Lepidopteran pheromones; exemption from the requirement of a tolerance.
Code of Federal Regulations, 2010 CFR
2010-07-01
... rate not to exceed 150 grams active ingredient/acre/year in accordance with good agricultural practices; and applied as a post-harvest treatment to stored food commodities at a rate not to exceed 3.5 grams active ingredient/1,000 ft2/year (equivalent to 150 grams active ingredient/acre/year) in accordance with...
Code of Federal Regulations, 2014 CFR
2014-04-01
... active ingredients offered for use in the treatment of hypophosphatemia. 310.541 Section 310.541 Food and... products containing active ingredients offered for use in the treatment of hypophosphatemia. (a) Hypophosphatemia is a condition in which an abnormally low plasma level of phosphate occurs in the blood. This...
Code of Federal Regulations, 2012 CFR
2012-04-01
... active ingredients offered for use in the treatment of hypophosphatemia. 310.541 Section 310.541 Food and... products containing active ingredients offered for use in the treatment of hypophosphatemia. (a) Hypophosphatemia is a condition in which an abnormally low plasma level of phosphate occurs in the blood. This...
Code of Federal Regulations, 2011 CFR
2011-04-01
... active ingredients offered for use in the treatment of hypophosphatemia. 310.541 Section 310.541 Food and... products containing active ingredients offered for use in the treatment of hypophosphatemia. (a) Hypophosphatemia is a condition in which an abnormally low plasma level of phosphate occurs in the blood. This...
Code of Federal Regulations, 2013 CFR
2013-04-01
... active ingredients offered for use in the treatment of hypophosphatemia. 310.541 Section 310.541 Food and... products containing active ingredients offered for use in the treatment of hypophosphatemia. (a) Hypophosphatemia is a condition in which an abnormally low plasma level of phosphate occurs in the blood. This...
Jiang, Li; Gao, Meng; Qu, Fei; Li, Hui-lan; Yu, Lan-bin; Rao, Yi; Wang, Yue-sheng; Xu, Guo-liang
2015-07-01
To establish a LC-MS/MS method to determine the concentrations of liquiritin, glycyrrhizin, glycyrrhetinic acid, amygdalin, amygdalin prunasin, ephedrine, pseudoephedrine and methylephedrine of Maxing Shigan decoction in rat plasma, and study the differences on their pharmacokinetic process in normal rats and RSV pneumonia model rats. After normal rats and RSV pneumonia model rats were orally administered with Maxing Shigan decoction, the blood was collected from retinal vein plexus of different time points. Specifically, tetrahydropalmatine was taken as internal standard for determining ephedrine, while chloramphenicol was taken as internal standard for determining other components. After plasma samples were pre-treated as the above, the supernatant was dried with nitrogen blowing concentrator and then redissolved with methylalcohol. The chromatography was eluted with mobile phase consisted of acetonitrile and 0.1% formic acid solution in a gradient manner. ESI sources were adopted to scan ingredients in ephedra in a positive ion scanning mode and other ingredientsin a negative ion scanning mode. The multiple-reaction monitoring (MRM) method was developed the plasma concentration of each active component. The pharmacokinetic parameters of each group were calculated by using Win-Nonlin 4.1 software and put into the statistical analysis. The result showed the plasma concentration of the eight active ingredients, i.e., liquiritin, glycyrrhizin, glycyrrhetinic acid, amygdalin, amygdalin prunasin, ephedrine, pseudoephedrine and methylephedrine within the ranges of 1.04-1040, 1.04-1040, 0.89-445, 1.05-4200, 1.25-2490, 0.3-480, 0.3-480, 0.3-480 microg x L(-1), with a good linearity and satisfactory precision, recovery and stability in the above ingredients. After modeling, except for glycyrrhetinic acid whose pharmacokinetic parameters were lacked due to the data missing, all of the rest components showed significant higher Cmax, AUC(0-1) and lower clearance rate (CL) than that of the normal group, indicating the increase in absorption in rats in the pathological state by reducing the clearance rate. The method is accurate and sensitive and so can be used to determine the plasma concentrations of the eight active ingredients in Maxing Shigan decoction. RSV pneumonia-infected rats absorbed more ingredients in Maxing Shigan decoction.
Unidentified Inert Ingredients in Pesticides: Implications for Human and Environmental Health
Cox, Caroline; Surgan, Michael
2006-01-01
Background By statute or regulation in the United States and elsewhere, pesticide ingredients are divided into two categories: active and inert (sometimes referred to as other ingredients, adjuvants, or coformulants). Despite their name, inert ingredients may be biologically or chemically active and are labeled inert only because of their function in the formulated product. Most of the tests required to register a pesticide are performed with the active ingredient alone, not the full pesticide formulation. Inert ingredients are generally not identified on product labels and are often claimed to be confidential business information. Objectives In this commentary, we describe the shortcomings of the current procedures for assessing the hazards of pesticide formulations and demonstrate that inert ingredients can increase the toxicity of and potential exposure to pesticide formulations. Discussion Inert ingredients can increase the ability of pesticide formulations to affect significant toxicologic end points, including developmental neurotoxicity, genotoxicity, and disruption of hormone function. They can also increase exposure by increasing dermal absorption, decreasing the efficacy of protective clothing, and increasing environmental mobility and persistence. Inert ingredients can increase the phytotoxicity of pesticide formulations as well as the toxicity to fish, amphibians, and microorganisms. Conclusions Pesticide registration should require full assessment of formulations. Evaluations of pesticides under the National Environmental Policy Act, the Endangered Species Act, and similar statutes should include impact assessment of formulations. Environmental monitoring for pesticides should include inert ingredients. To enable independent research and risk assessment, inert ingredients should be identified on product labels. PMID:17185266
Code of Federal Regulations, 2010 CFR
2010-07-01
... 40 Protection of Environment 29 2010-07-01 2010-07-01 false Organic Pesticide Active Ingredient New Source Performance Standards (NSPS) and Pretreatment Standards for New Sources (PSNS) 3 Table 3 to... STANDARDS PESTICIDE CHEMICALS Pt. 455, Table 3 Table 3 to Part 455—Organic Pesticide Active Ingredient New...
Code of Federal Regulations, 2011 CFR
2011-07-01
... 40 Protection of Environment 30 2011-07-01 2011-07-01 false Organic Pesticide Active Ingredient New Source Performance Standards (NSPS) and Pretreatment Standards for New Sources (PSNS) 3 Table 3 to... STANDARDS PESTICIDE CHEMICALS Pt. 455, Table 3 Table 3 to Part 455—Organic Pesticide Active Ingredient New...
40 CFR 152.85 - Formulators' exemption.
Code of Federal Regulations, 2010 CFR
2010-07-01
... the formulators' exemption applies usually will concern the safety of one or more of the product's... ingredient, the pure active ingredient, the radiolabeled pure active ingredient, or a typical end-use product... to data on the applicant's product itself, including the safety or efficacy of the product, unless...
40 CFR 152.85 - Formulators' exemption.
Code of Federal Regulations, 2012 CFR
2012-07-01
... the formulators' exemption applies usually will concern the safety of one or more of the product's... ingredient, the pure active ingredient, the radiolabeled pure active ingredient, or a typical end-use product... to data on the applicant's product itself, including the safety or efficacy of the product, unless...
40 CFR 152.85 - Formulators' exemption.
Code of Federal Regulations, 2011 CFR
2011-07-01
... the formulators' exemption applies usually will concern the safety of one or more of the product's... ingredient, the pure active ingredient, the radiolabeled pure active ingredient, or a typical end-use product... to data on the applicant's product itself, including the safety or efficacy of the product, unless...
40 CFR 152.85 - Formulators' exemption.
Code of Federal Regulations, 2014 CFR
2014-07-01
... the formulators' exemption applies usually will concern the safety of one or more of the product's... ingredient, the pure active ingredient, the radiolabeled pure active ingredient, or a typical end-use product... to data on the applicant's product itself, including the safety or efficacy of the product, unless...
40 CFR 152.85 - Formulators' exemption.
Code of Federal Regulations, 2013 CFR
2013-07-01
... the formulators' exemption applies usually will concern the safety of one or more of the product's... ingredient, the pure active ingredient, the radiolabeled pure active ingredient, or a typical end-use product... to data on the applicant's product itself, including the safety or efficacy of the product, unless...
Li, Huiying; Zhao, Linhua; Zhang, Bo; Jiang, Yuyu; Wang, Xu; Guo, Yun; Liu, Hongxing; Li, Shao; Tong, Xiaolin
2014-01-01
Traditional Chinese medicine (TCM) herbal formulae can be valuable therapeutic strategies and drug discovery resources. However, the active ingredients and action mechanisms of most TCM formulae remain unclear. Therefore, the identification of potent ingredients and their actions is a major challenge in TCM research. In this study, we used a network pharmacology approach we previously developed to help determine the potential antidiabetic ingredients from the traditional Ge-Gen-Qin-Lian decoction (GGQLD) formula. We predicted the target profiles of all available GGQLD ingredients to infer the active ingredients by clustering the target profile of ingredients with FDA-approved antidiabetic drugs. We also applied network target analysis to evaluate the links between herbal ingredients and pharmacological actions to help explain the action mechanisms of GGQLD. According to the predicted results, we confirmed that a novel antidiabetic ingredient from Puerariae Lobatae radix (Ge-Gen), 4-Hydroxymephenytoin, increased the insulin secretion in RIN-5F cells and improved insulin resistance in 3T3-L1 adipocytes. The network pharmacology strategy used here provided a powerful means for identifying bioactive ingredients and mechanisms of action for TCM herbal formulae, including Ge-Gen-Qin-Lian decoction. PMID:24527048
21 CFR 212.50 - What production and process controls must I have?
Code of Federal Regulations, 2010 CFR
2010-04-01
... containers, closures, and packaging materials, including a specimen or copy of each label and all other..., the name and radioactivity or other measurement of each active pharmaceutical ingredient and each... active pharmaceutical ingredient and each inactive ingredient per batch or per unit of radioactivity or...
He, Hao; Yu, Wan-Guo; Yang, Jun-Peng; Ge, Sheng; Lu, Yan-Hua
2016-03-30
Glucokinase (GK) activity, which is rapidly regulated by glucokinase regulatory protein (GKRP) in the liver, is crucial for blood glucose homeostasis. In this paper, the GK activation mechanisms of 1-deoxynojrimycin (DNJ), resveratrol (RES), oxyresveratrol (OXY), cyanidin-3-glucoside (C3G), and cyanidin-3-rutinoside (C3R) were compared. The results revealed that DNJ, RES, C3G, and C3R could differently improve glucose consumption and enhance intracellular GK activities. DNJ and RES significantly promoted GK translocation at 12.5 μM, whereas other ingredients showed moderate effects. DNJ, C3G, and C3R could rupture intramolecular hydrogen bonds of GK to accelerate its allosteric activation at early stage. RES and OXY could bind to a "hydrophobic pocket" on GK to stabilize the active GK at the final stage. Otherwise, RES, OXY, C3G, and C3R could interact with GKRP at the F1P binding site to promote GK dissociation and translocation. Enzymatic assay showed that RES (15-50 μM) and OXY (25-50 μM) could significantly enhance GK activities, which was caused by their binding properties with GK. Moreover, the most dramatic up-regulation effects on GK expression were observed in C3G and C3R groups. This work expounded the differences between GK activation mechanisms, and the new findings would help to develop new GK activators.
Encapsulation of cosmetic active ingredients for topical application--a review.
Casanova, Francisca; Santos, Lúcia
2016-02-01
Microencapsulation is finding increasing applications in cosmetics and personal care markets. This article provides an overall discussion on encapsulation of cosmetically active ingredients and encapsulation techniques for cosmetic and personal care products for topical applications. Some of the challenges are identified and critical aspects and future perspectives are addressed. Many cosmetics and personal care products contain biologically active substances that require encapsulation for increased stability of the active materials. The topical and transdermal delivery of active cosmetic ingredients requires effective, controlled and safe means of reaching the target site within the skin. Preservation of the active ingredients is also essential during formulation, storage and application of the final cosmetic product. Microencapsulation offers an ideal and unique carrier system for cosmetic active ingredients, as it has the potential to respond to all these requirements. The encapsulated agent can be released by several mechanisms, such as mechanical action, heat, diffusion, pH, biodegradation and dissolution. The selection of the encapsulation technique and shell material depends on the final application of the product, considering physical and chemical stability, concentration, required particle size, release mechanism and manufacturing costs.
Herbal Supplements for Prostate Enlargement: Current State of the Evidence.
Nabavizadeh, Reza; Zangi, Mahdi; Kim, Michelle M; Yavari Bejestani, Maryam; Tabatabaei, Shahin
2018-02-01
To provide a comprehensive review of the current state of herbal supplement market for lower urinary tract symptoms (LUTS) and correlate the ingredients of each product with available scientific evidence. Twenty-seven products from Amazon.com that were advertised as herbal supplements for LUTS and had listed their active ingredients were selected. Active ingredients were reviewed on Google Scholar. Product price, warranty, and consumer review information were also collected. A total of 58 unique active ingredients were identified. The mean number of ingredients was 8.26 (standard deviation 5.25). Whereas 17 (63%) products had an ingredient with a systematic review to support their use, 20 (74%) had an ingredient with conflicting evidence based on systematic reviews. Out of the supplements that contained ingredients supported by literature, all (100%) products simultaneously had other ingredients with no, conflicting, or refuting evidence. There was no (0%) product that contained only scientifically proven ingredients. There is no scientific study to evaluate these supplements as a whole. Despite the widespread use of herbal supplements for LUTS, there is scant scientific evidence to support their safety and efficacy. Lack of adequate regulation and government support for research and development are some of the factors that disincentivize researchers to study safety and efficacy of these products. We encourage physicians to warn their patients on the lack of adequate evidence to support the safety and efficacy of many of these supplements. Copyright © 2017 Elsevier Inc. All rights reserved.
Zuzana, Vitková; Petra, Herdová; Jozef, Cižmárik; Daniel, Grančai; Lukáš, Benč
2012-06-01
The paper examines the formulation of hydrogel on the base of a synthetic polymer containing a local anaesthetic and a mass-produced drug in the form of a solution with an antiphlogistic effect. It aimed to prepare a hydrogel of a suitable composition with suitable flow properties and drug release, the active ingredient being lidocaine hydrochloride. Besides the role of a synthetic polymer which ensures that the active ingredient remains at the affected site, an important role in the formulation is played by the presence of an artificial sweetener, which to a great extent as a taste correcting agent of the unpleasant taste of the active ingredient influences the compliance of many patients. The study examined the effect of concentration of the artificial sweetener xylitol on the liberation of the active ingredient from prepared hydrogels. The optimum concentration of the artificial sweetener was adjusted to a degree which does not affect the qualitative properties of the active ingredient. lidocaine hydrochloride, xylitol, hydrogel, liberation.
NASA Astrophysics Data System (ADS)
Li, X.; Xu, L. Y.; Cui, Y. Q.; Pang, M. X.; Wang, F.; Qi, J. H.
2018-01-01
Extraction and anti-bacteria effect of active ingredients of Siraitia grosvenorii were studied in this paper. Extraction combined with ultrasonic was adopted. The optimum extraction condition was determined by single factor test; the anti-bacteria effect of active ingredients and minimum inhibitory concentration (MIC) were valued by Oxford-cup method. The results indicated that optimum extraction condition of active ingredients extracted from Siraitia grosvenorii were described as follows: ethanol concentrations of sixty-five percent and twenty minutes with ultrasonic assisted extraction; the active ingredients of Siraitia grosvenorii had anti-bacteria effect on Staphylococcus epidermidis, Proteus vulgaris, Bacillus sp, Serratia sp and MIC was 0.125g/mL, 0.0625g/mL, 0.125g/mL and 0.125g/mL. The active constituent of Siraitia grosvenorii has obvious anti-bacteria effect on the spoilage bacteria isolated from Sauced pork head meat and can be used as a new natural food preservation to prolong the shelf-life of Low-temperature meat products.
Inventions on baker's yeast strains and specialty ingredients.
Gélinas, Pierre
2009-06-01
Baker's yeast is one of the oldest food microbial starters. Between 1927 and 2008, 165 inventions on more than 337 baker's yeast strains were patented. The first generation of patented yeast strains claimed improved biomass yield at the yeast plant, higher gassing power in dough or better survival to drying to prepare active dry baker's yeast. Especially between 1980 and 1995, a major interest was given to strains for multiple bakery applications such as dough with variable sugar content and stored at refrigeration (cold) or freezing temperatures. During the same period, genetically engineered yeast strains became very popular but did not find applications in the baking industry. Since year 2000, patented baker's yeast strains claimed aroma, anti-moulding or nutritive properties to better meet the needs of the baking industry. In addition to patents on yeast strains, 47 patents were issued on baker's yeast specialty ingredients for niche markets. This review shows that patents on baker's yeast with improved characteristics such as aromatic or nutritive properties have regularly been issued since the 1920's. Overall, it also confirms recent interest for a very wide range of tailored-made yeast-based ingredients for bakery applications.
Goldsmith, M-R; Grulke, C M; Brooks, R D; Transue, T R; Tan, Y M; Frame, A; Egeghy, P P; Edwards, R; Chang, D T; Tornero-Velez, R; Isaacs, K; Wang, A; Johnson, J; Holm, K; Reich, M; Mitchell, J; Vallero, D A; Phillips, L; Phillips, M; Wambaugh, J F; Judson, R S; Buckley, T J; Dary, C C
2014-03-01
Consumer products are a primary source of chemical exposures, yet little structured information is available on the chemical ingredients of these products and the concentrations at which ingredients are present. To address this data gap, we created a database of chemicals in consumer products using product Material Safety Data Sheets (MSDSs) publicly provided by a large retailer. The resulting database represents 1797 unique chemicals mapped to 8921 consumer products and a hierarchy of 353 consumer product "use categories" within a total of 15 top-level categories. We examine the utility of this database and discuss ways in which it will support (i) exposure screening and prioritization, (ii) generic or framework formulations for several indoor/consumer product exposure modeling initiatives, (iii) candidate chemical selection for monitoring near field exposure from proximal sources, and (iv) as activity tracers or ubiquitous exposure sources using "chemical space" map analyses. Chemicals present at high concentrations and across multiple consumer products and use categories that hold high exposure potential are identified. Our database is publicly available to serve regulators, retailers, manufacturers, and the public for predictive screening of chemicals in new and existing consumer products on the basis of exposure and risk. Published by Elsevier Ltd.
Pharmacology and toxicology of Cannabis derivatives and endocannabinoid agonists.
Gerra, Gilberto; Zaimovic, Amir; Gerra, Maria L; Ciccocioppo, Roberto; Cippitelli, Andrea; Serpelloni, Giovanni; Somaini, Lorenzo
2010-01-01
For centuries Cannabis sativa and cannabis extracts have been used in natural medicine. Delta(9)-tetrahydrocannabinol (THC) is the main active ingredient of Cannabis. THC seems to be responsible for most of the pharmacological and therapeutic actions of cannabis. In a few countries THC extracts (i.e. Sativex) or THC derivatives such as nabilone, and dronabinol are used in the clinic for the treatment of several pathological conditions like chemotherapy-induced nausea and vomiting, multiple sclerosis and glaucoma. On the other hand the severe side effects and the high abuse liability of these agents represent a serious limitation in their medical use. In addition, diversion in the use of these active ingredients for recreational purpose is a concern. Over recent years, alternative approaches using synthetic cannabinoid receptor agonists or agents acting as activators of the endocannabinoid systems are under scrutiny with the hope to develop more effective and safer clinical applications. Likely, in the near future few of these new molecules will be available for clinical use. The present article review recent study and patents with focus on the cannabinoid system as a target for the treatment of central nervous system disorders with emphasis on agonists.
21 CFR 212.1 - What are the meanings of the technical terms used in these regulations?
Code of Federal Regulations, 2011 CFR
2011-04-01
... permit the use of a component, container and closure, in-process material, packaging material, or..., and Cosmetic Act, as amended (21 U.S.C. 321 et seq.). Active pharmaceutical ingredient means a... ingredient means any intended component of the PET drug other than the active pharmaceutical ingredient. In...
Lim, Yeni; Ahn, Yoon Hee; Yoo, Jae Keun; Park, Kyoung Sik; Kwon, Oran
2017-09-01
Sales of multivitamins have been growing rapidly and the concept of natural multivitamin, plant-based multivitamin, or both has been introduced in the market, leading consumers to anticipate additional health benefits from phytochemicals that accompany the vitamins. However, the lack of labeling requirements might lead to fraudulent claims. Therefore, the objective of this study was to develop a strategy to verify identity of plant-based multivitamins. Phytochemical fingerprinting was used to discriminate identities. In addition, multiple bioassays were performed to determine total antioxidant capacity. A statistical computation model was then used to measure contributions of phytochemicals and vitamins to antioxidant activities. Fifteen multivitamins were purchased from the local markets in Seoul, Korea and classified into three groups according to the number of plant ingredients. Pearson correlation analysis among antioxidant capacities, amount phenols, and number of plant ingredients revealed that ferric reducing antioxidant power (FRAP) and 2,2-diphenyl-1-picryhydrazyl (DPPH) assay results had the highest correlation with total phenol content. This suggests that FRAP and DPPH assays are useful for characterizing plant-derived multivitamins. Furthermore, net effect linear regression analysis confirmed that the contribution of phytochemicals to total antioxidant capacities was always relatively higher than that of vitamins. Taken together, the results suggest that phytochemical fingerprinting in combination with multiple bioassays could be used as a strategy to determine whether plant-derived multivitamins could provide additional health benefits beyond their nutritional value.
What do We Know about Family Interventions for Psychosis at the Process Level? A Systematic Review.
Grácio, Jaime; Gonçalves-Pereira, Manuel; Leff, Julian
2016-03-01
The evidence regarding effectiveness of family interventions for psychosis (FIP) is strong and consistent. However, there is a gap in the research on the process of these interventions, and little is known about their active ingredients. This review aims to identify the active ingredients of FIP. We conducted a systematic literature review, focusing on qualitative research, and analyzed 22 papers in total. We found a single study comprehensively exploring the process of FIP. All other studies focused on particular aspects of process-related variables. The key elements of FIP seem to be the so-called "common therapeutic factors", followed by education about the illness and coping skills training. This review supports the value of a stepped model of intervention according to the needs of the families. However, the evidence reviewed also reveals a gap in the research findings based on the limited research available. FIP are complex, psychosocial interventions with multiple components, and more intensive, qualitative research is needed to establish linkages between process and outcome. © 2015 Family Process Institute.
Advance in Anti-tumor Mechanisms of Shikonin, Alkannin and their Derivatives.
Zhang, Xu; Cui, Jia-Hua; Meng, Qing-Qing; Li, Shao-Shun; Zhou, Wen; Xiao, Sui
2018-01-01
Shikonin, alkannin and their derivatives, the main ingredient of Lithospermum erythrorhizon and Arnebia euchroma (Royle) Johnst native to Inner Mongolian and Northwest of China respectively, hold promising potentials for antitumor effects via multiple-target mechanisms. This review will emphasize the importance of their antitumor activity in apoptosis, necroptosis and immunogenic cell death, and expound the relationship of their antitumor activity and naphthoquinone scaffold that could generate ROS and alkylating agent. Meanwhile, the antitumor mechanisms of naturally-occurring shikonin, alkannin and their derivatives, which were divided into the direct interaction involved in alkylating agent, covalently binding the DNA and protein, as well as the indirect interaction mediated by ROS, nonspecifically influencing the mitochondria or multiple signal pathways, will be systematically summarized and discussed. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.
Chemically-related Groups of Active Ingredients
Many pesticide active ingredients affect pests in similar ways, and we re-evaluate them together as a group. Groups include carbamate insecticides, neonicotinoids, organochlorines, organophosphates, pyrethrins, and pyrethroids.
Jamal, Salma; Scaria, Vinod
2014-01-01
Background. Traditional Chinese medicine encompasses a well established alternate system of medicine based on a broad range of herbal formulations and is practiced extensively in the region for the treatment of a wide variety of diseases. In recent years, several reports describe in depth studies of the molecular ingredients of traditional Chinese medicines on the biological activities including anti-bacterial activities. The availability of a well-curated dataset of molecular ingredients of traditional Chinese medicines and accurate in-silico cheminformatics models for data mining for antitubercular agents and computational filters to prioritize molecules has prompted us to search for potential hits from these datasets. Results. We used a consensus approach to predict molecules with potential antitubercular activities from a large dataset of molecular ingredients of traditional Chinese medicines available in the public domain. We further prioritized 160 molecules based on five computational filters (SMARTSfilter) so as to avoid potentially undesirable molecules. We further examined the molecules for permeability across Mycobacterial cell wall and for potential activities against non-replicating and drug tolerant Mycobacteria. Additional in-depth literature surveys for the reported antitubercular activities of the molecular ingredients and their sources were considered for drawing support to prioritization. Conclusions. Our analysis suggests that datasets of molecular ingredients of traditional Chinese medicines offer a new opportunity to mine for potential biological activities. In this report, we suggest a proof-of-concept methodology to prioritize molecules for further experimental assays using a variety of computational tools. We also additionally suggest that a subset of prioritized molecules could be used for evaluation for tuberculosis due to their additional effect against non-replicating tuberculosis as well as the additional hepato-protection offered by the source of these ingredients.
Jamal, Salma
2014-01-01
Background. Traditional Chinese medicine encompasses a well established alternate system of medicine based on a broad range of herbal formulations and is practiced extensively in the region for the treatment of a wide variety of diseases. In recent years, several reports describe in depth studies of the molecular ingredients of traditional Chinese medicines on the biological activities including anti-bacterial activities. The availability of a well-curated dataset of molecular ingredients of traditional Chinese medicines and accurate in-silico cheminformatics models for data mining for antitubercular agents and computational filters to prioritize molecules has prompted us to search for potential hits from these datasets. Results. We used a consensus approach to predict molecules with potential antitubercular activities from a large dataset of molecular ingredients of traditional Chinese medicines available in the public domain. We further prioritized 160 molecules based on five computational filters (SMARTSfilter) so as to avoid potentially undesirable molecules. We further examined the molecules for permeability across Mycobacterial cell wall and for potential activities against non-replicating and drug tolerant Mycobacteria. Additional in-depth literature surveys for the reported antitubercular activities of the molecular ingredients and their sources were considered for drawing support to prioritization. Conclusions. Our analysis suggests that datasets of molecular ingredients of traditional Chinese medicines offer a new opportunity to mine for potential biological activities. In this report, we suggest a proof-of-concept methodology to prioritize molecules for further experimental assays using a variety of computational tools. We also additionally suggest that a subset of prioritized molecules could be used for evaluation for tuberculosis due to their additional effect against non-replicating tuberculosis as well as the additional hepato-protection offered by the source of these ingredients. PMID:25081126
Fixed-dose combination and single active ingredient drugs: a comparative cost analysis.
Hao, Jing; Rodriguez-Monguio, Rosa; Seoane-Vazquez, Enrique
2016-01-01
Fixed-dose combination (FDC) drugs are formulations of two or more active ingredients. To assess the pricing structure and price difference of all US FDA-approved FDCs and single drugs included in the combination. Data were collected from the FDA Orange Book and Drugs@FDA. Average Wholesale Price (AWP) unit price data were derived from The Red Book. The FDA approved 117 FDC. The average AWP difference percentage between the FDC and the sum of the single drugs in the FDC is 84.9 ± 26.2%, and varied by therapeutic class (p < 0.001). The FDC AWP averaged 83.3 ± 23.4% of the single drug AWP sum when there are no generics, and 95.1 ± 42.3% (p < 0.01) when there are two generic single active ingredients in the FDC. The price difference between FDC and single active ingredients in the combination is correlated with the therapeutic class, the year of FDC approval, and the number of single ingredients in the combination that have generics.
NASA Astrophysics Data System (ADS)
Chen, Jian-bo; Sun, Su-qin; Tang, Xu-dong; Zhang, Jing-zhao; Zhou, Qun
2016-08-01
Herbal powder preparation is a kind of widely-used herbal product in the form of powder mixture of herbal ingredients. Identification of herbal ingredients is the first and foremost step in assuring the quality, safety and efficacy of herbal powder preparations. In this research, Fourier transform infrared (FT-IR) microspectroscopic identification method is proposed for the direct and simultaneous recognition of multiple organic and inorganic ingredients in herbal powder preparations. First, the reference spectrum of characteristic particles of each herbal ingredient is assigned according to FT-IR results and other available information. Next, a statistical correlation threshold is determined as the lower limit of correlation coefficients between the reference spectrum and a larger number of calibration characteristic particles. After validation, the reference spectrum and correlation threshold can be used to identify herbal ingredient in mixture preparations. A herbal ingredient is supposed to be present if correlation coefficients between the reference spectrum and some sample particles are above the threshold. Using this method, all kinds of herbal materials in powder preparation Kouqiang Kuiyang San are identified successfully. This research shows the potential of FT-IR microspectroscopic identification method for the accurate and quick identification of ingredients in herbal powder preparations.
[Study on the effect using hemoperfusion to treat tylenol poisoned patients].
Lai, Deng-pan; Ren, Xian-hua; Yao, Ju-ping; Liu, Mao-lin; Xu, Gang; Chen, Zhao-jun; Ling, Gui-lan
2012-04-01
To explore the effect of hemoperfusion (HP) on tylenol poisoned patients. Urgently established the blood access by transfemoral catheterization of femoral vein, we used charcoal hemoperfusion by blood pump and dynamically monitored the plasma concentration of tylenol active ingredients for the 2 patients and the content of tylenol active ingredients in the charcoal was determined. Plasma concentration of tylenol active ingredients of the 2 patients was declined gradually during and after the HP management. The acetaminophen serum concentration of the case 1 was declined from the 13.4 µg/L at the start of HP to the 5.81 µg/L at the end of HP; and the case 2 was declined from 51.1 µg/L to 22.3 µg/L. The adsorption amount of acetaminophen in the blood perfusion device are respectively 119 542 µg of case 1 and 33 2154 µg of case 2. Early hemoperfusion should be carried out for acute tylenol poisoning patients if there were indications, hemoperfusion can clear the tylenol active ingredients and this is an effective measure to eliminate tylenol active ingredients.
Federal Register 2010, 2011, 2012, 2013, 2014
2011-10-11
... Activities; Submission to OMB for Review and Approval; Comment Request; NESHAP for Pesticide Active... . Title: NESHAP for Pesticide Active Ingredient Production (Renewal). ICR Numbers: EPA ICR Number 1807.05... Air Pollutants (NESHAP) for Pesticide Active Ingredient Production were proposed on November 10, 1997...
Campbell, Gossett A; Vallejo, Erick
2015-01-01
The packaging presentation of oral liquid pediatric medicines is a critical step in maintaining chemical and physical stability, compliance, adherence, and proper handling by the target patient population, guardians, caregivers, and health-care professionals. The common packaging presentations for commercial oral liquid pediatric drug products are glass bottle, plastic bottle, sachet, and stick pack configurations. The type of pack presentation selected is driven by the quality target product profile (QTPP) that is designed around the physicochemical properties of the drug substance and the desired drug product suitability for the target population. The QTPP defines the intended use of the drug product, drug product quality criteria, dose strength, dosage form, container closure system, storage conditions, stability criteria, dosing device, shelf life, and attributes affecting the pharmacokinetic characteristics. Oral liquid pediatric formulations are typically prepared from a powder that is constituted at the time of use as a suspension or a solution for single or multiple use depending on the stability of the constituted formulation. Active ingredients with high aqueous solubility can be developed as a powder for oral solution and presented in a bottle for multiple use product and a stick pack, packet, or sachet for single-use product. Active ingredients with low aqueous solubility can be developed as a powder for oral suspension and presented in a bottle for multiple use product and a stick pack or sachet for single-use product. A secondary package may be used in cases where the primary pack failed to provide adequate protection against light degradation. This work will help formulation scientists select the most appropriate pack presentation in the early stages of pediatric clinical development. © 2014 Wiley Periodicals, Inc. and the American Pharmacists Association.
Feasibility of Raman spectroscopy as PAT tool in active coating.
Müller, Joshua; Knop, Klaus; Thies, Jochen; Uerpmann, Carsten; Kleinebudde, Peter
2010-02-01
Active coating is a specific application of film coating where the active ingredient is comprised in the coating layer. This implementation is a challenging operation regarding the achievement of desired amount of coating and coating uniformity. To guarantee the quality of such dosage forms it is desirable to develop a tool that is able to monitor the coating operation and detect the end of the process. Coating experiments were performed at which the model drug diprophylline is coated in a pan coater on placebo tablets and tablets containing the active ingredient itself. During the active coating Raman spectra were recorded in-line. The spectral measurements were correlated with the average weight gain and the amount of coated active ingredient at each time point. The developed chemometric model was tested by monitoring further coated batches. Furthermore, the effects of pan rotation speed and working distance on the acquired Raman signal and, hence, resulting effect of the chemometric model were examined. Besides coating on placebo cores it was possible to determine the amount of active ingredient in the film when coated onto cores containing the same active ingredient. In addition, the method is even applicable when varying the process parameters and measurement conditions within a restricted range. Raman spectroscopy is an appropriate process analytical technology too.
A Multiscale Survival Process for Modeling Human Activity Patterns.
Zhang, Tianyang; Cui, Peng; Song, Chaoming; Zhu, Wenwu; Yang, Shiqiang
2016-01-01
Human activity plays a central role in understanding large-scale social dynamics. It is well documented that individual activity pattern follows bursty dynamics characterized by heavy-tailed interevent time distributions. Here we study a large-scale online chatting dataset consisting of 5,549,570 users, finding that individual activity pattern varies with timescales whereas existing models only approximate empirical observations within a limited timescale. We propose a novel approach that models the intensity rate of an individual triggering an activity. We demonstrate that the model precisely captures corresponding human dynamics across multiple timescales over five orders of magnitudes. Our model also allows extracting the population heterogeneity of activity patterns, characterized by a set of individual-specific ingredients. Integrating our approach with social interactions leads to a wide range of implications.
Hameury, Sebastien; Borderie, Laurent; Monneuse, Jean-Marc; Skorski, Gilbert; Pradines, Dominique
2018-05-23
The application of ingredients from marine and maritime origins is increasingly common in skin care products, driven by consumer expectations for natural ingredients. However, these ingredients are typically studied for a few isolated in vitro activities. The purpose of this study was to carry out a comprehensive evaluation of the activity on the skin of an association of ingredients from marine and maritime origins using label-free quantitative proteomic analysis, in order to predict the clinical benefits if used in a skin care product. An aqueous gel containing 6.1% of ingredients from marine and maritime origins (amino acid-enriched giant kelp extract, trace element-enriched seawater, dedifferentiated sea fennel cells) was topically applied on human skin explants. The skin explants' proteome was analyzed in a label-free manner by high-performance liquid nano-chromatography coupled with tandem mass spectrometry. A specific data processing pipeline (CORAVALID) providing an objective and comprehensive interpretation of the statistically relevant biological activities processed the results. Compared to untreated skin explants, 64 proteins were significantly regulated by the gel treatment (q-value ≤ 0.05). Computer data processing revealed an activity of the ingredients on the epidermis and the dermis. These significantly regulated proteins are involved in gene expression, cell survival and metabolism, inflammatory processes, dermal extracellular matrix synthesis, melanogenesis and keratinocyte proliferation, migration, and differentiation. These results suggest that the tested ingredients could help to preserve a healthy epidermis and dermis, and possibly to prevent the visible signs of skin aging. © 2018 The Authors. Journal of Cosmetic Dermatology Published by Wiley Periodicals, Inc.
Rapid analysis of controlled substances using desorption electrospray ionization mass spectrometry.
Rodriguez-Cruz, Sandra E
2006-01-01
The recently developed technique of desorption electrospray ionization (DESI) has been applied to the rapid analysis of controlled substances. Experiments have been performed using a commercial ThermoFinnigan LCQ Advantage MAX ion-trap mass spectrometer with limited modifications. Results from the ambient sampling of licit and illicit tablets demonstrate the ability of the DESI technique to detect the main active ingredient(s) or controlled substance(s), even in the presence of other higher-concentration components. Full-scan mass spectrometry data provide preliminary identification by molecular weight determination, while rapid analysis using the tandem mass spectrometry (MS/MS) mode provides fragmentation data which, when compared to the laboratory-generated ESI-MS/MS spectral library, provide structural information and final identification of the active ingredient(s). The consecutive analysis of tablets containing different active components indicates there is no cross-contamination or interference from tablet to tablet, demonstrating the reliability of the DESI technique for rapid sampling (one tablet/min or better). Active ingredients have been detected for tablets in which the active component represents less than 1% of the total tablet weight, demonstrating the sensitivity of the technique. The real-time sampling of cannabis plant material is also presented.
[Several changes of Indocalamus leaf active ingredients contents].
Su, Chun-hua; Liu, Guo-hua; Wang, Fu-sheng; Ding, Yu-long; Xue, Jian-hui
2011-09-01
In this paper, the leaves of Indocalamus herklotsii, Indocalamus decorus, and Indocalamus latifolius were collected from Nanjing in different seasons to study the seasonal changes of the total flavonoids, tea polyphenols, and soluble sugar contents in the leaves. There existed significant differences in the test active ingredients contents among the leaves of the three Indocalamus species. The leaf total flavonoids content of the three Indocalamus species in different seasons ranged in 1.7%-2.7%, being the highest for I. herklotsii and I. decorus in spring and for I. latifolius in winter. The leaf tea polyphenols content varied from 5.5% to 7.6%; and the leaf soluble sugar content was 1.0%-8.5%, with the maximum in spring. Within the three months after leaf unfolding, the active ingredients contents in I. herklotsii and I. decorus leaves increased with leaf age. The optimal period for harvesting Indocalamus leaves was from December to next March. Among the three Indocalamus species, I. latifolius had the highest contents of the three active ingredients in leaves, suggesting that I. latifolius had greater potential value in the utilization of its leaf active ingredients than the other two species.
Federal Register 2010, 2011, 2012, 2013, 2014
2011-06-17
... of sunscreen active ingredients and propellants? What are typical particle size distributions for... risks associated with inhalation of sunscreen active ingredients and propellants?), we request...
Study on THz spectra of the active ingredients in the TCM
NASA Astrophysics Data System (ADS)
Ma, ShiHua; Wang, WenFeng; Liu, GuiFeng; Ge, Min; Zhu, ZhiYong
2008-03-01
Terahertz spectroscopy has tremendous potential for applications to evaluate the quality of the drugs including the TCM. In this paper, the Terahertz Time-Domain Spectroscopy investigated two active ingredients: Andrographolide and Dehydroandrographoline, isolated from Andrographis paniculata (Burm. f.) Nees. We also measured the mixtures of two active ingredients at the different ratio and the quantitative analysis is also applied to determine the contents of compound. The Terahertz spectroscopy is a potential and promising technique in identifying the components, evaluating the drugs sanitation and inspecting the quality of medicine including TCM.
40 CFR 162.152 - State registration authority.
Code of Federal Regulations, 2011 CFR
2011-07-01
... packaging, or in the identity of the formulator. (B) A product which contains the same active and inert... of paragraph (b)(2)(ii) of this section, a product containing a new combination of active, or active and inert, ingredients. (ii) A State may register a new product only if each of the active ingredients...
40 CFR 162.152 - State registration authority.
Code of Federal Regulations, 2010 CFR
2010-07-01
... packaging, or in the identity of the formulator. (B) A product which contains the same active and inert... of paragraph (b)(2)(ii) of this section, a product containing a new combination of active, or active and inert, ingredients. (ii) A State may register a new product only if each of the active ingredients...
Development of a Consumer Product Ingredient Database for ...
Consumer products are a primary source of chemical exposures, yet little structured information is available on the chemical ingredients of these products and the concentrations at which ingredients are present. To address this data gap, we created a database of chemicals in consumer products using product Material Safety Data Sheets (MSDSs) publicly provided by a large retailer. The resulting database represents 1797 unique chemicals mapped to 8921 consumer products and a hierarchy of 353 consumer product “use categories” within a total of 15 top-level categories. We examine the utility of this database and discuss ways in which it will support (i) exposure screening and prioritization, (ii) generic or framework formulations for several indoor/consumer product exposure modeling initiatives, (iii) candidate chemical selection for monitoring near field exposure from proximal sources, and (iv) as activity tracers or ubiquitous exposure sources using “chemical space” map analyses. Chemicals present at high concentrations and across multiple consumer products and use categories that hold high exposure potential are identified. Our database is publicly available to serve regulators, retailers, manufacturers, and the public for predictive screening of chemicals in new and existing consumer products on the basis of exposure and risk. The National Exposure Research Laboratory’s (NERL’s) Human Exposure and Atmospheric Sciences Division (HEASD) conducts resear
Deacon, S P; Paddle, G M
1998-05-01
A health surveillance study of male grain food manufacturing workers used a respiratory health questionnaire and spirometry to assess the prevalence of work-related respiratory symptoms and impaired ventilatory performance. The prevalence of cough, breathlessness, wheeze and chest tightness was between 8-13% but was 20% for rhinitis. Rhinitis was the most common symptom with 37% of those reporting rhinitis describing this as work-related. A case-control analysis of workers reporting rhinitis did not identify any specific occupational activities associated with increased risk of rhinitis. Smoking habit and all respiratory symptoms apart from rhinitis had a significant effect upon ventilatory performance. Occupational exposure to raw grains, flour, ingredients and finished food was categorized as high, medium or low in either continuous or intermediate patterns. Multiple regression analysis confirmed the effects of height, age and smoking upon ventilatory performance. However, occupational exposure to grain, flour, food ingredients and cooked food dusts had no effect upon ventilatory performance. It is concluded that smoking habit is the major determinant of respiratory symptoms and impaired ventilatory function. The excess complaints of rhinitis warrant further study but it would appear that the current occupational exposure limits for grain, flour, food ingredients and cooked food dusts are adequate to protect workers against impairment of ventilatory performance.
Mavon, A
2015-10-01
The megatrend of population ageing is leading to a growing demand for "anti-ageing" treatments, especially to prevent or treat skin ageing. Facing an increasing offer, consumers are choosing more and more skin care products supported by a scientific rationale, active ingredients and clinical proof of efficacy. Considering consumer expectations, this research led to the discovery of acetyl aspartic acid (A-A-A), a novel active ingredient to improve sagging skin and loss of skin firmness. This supplement is featuring seven manuscripts aiming at presenting the research and investigations from consumer insights, discovery of A-A-A, its in vitro activity confirmation, safety assessment, formulation and its dermal absorption to the clinical proof of efficacy, investigated through two pilots' double bind randomized and placebo controlled studies on photo-aged skin. This extensive research enabled us to discover A-A-A, as an active ingredient with potential to repair sign of skin ageing and supported by clinical proof of efficacy. This active ingredient will be soon launched in a commercial innovative skin care range, delivering desirable anti-wrinkle and skin lifting benefits. © 2015 Society of Cosmetic Scientists and the Société Française de Cosmétologie.
Topical rosacea therapy: the importance of vehicles for efficacy, tolerability and compliance.
Jackson, J Mark; Pelle, Michelle
2011-06-01
Many topical medications are available for the treatment of papulopustular rosacea. While treatments contain metronidazole, azelaic acid, or sodium sulfacetamide-sulfur as the active ingredient, the composition of the vehicle formulations varies widely. These vehicles come in gels, creams, lotions and foams; some ingredients are common to many vehicles, while some vehicles contain unique ingredients designed to optimize skin penetration and delivery of the active drug to its target. Vehicles can also influence tolerability, which is always a concern in patients with heightened skin sensitivity, and compliance, which is typically lower for topical treatments than oral treatments. Ideally, the vehicle of any rosacea treatment should enhance drug delivery, be nonirritating and be easy to use. Ingredients that help repair barrier function are also desirable. This review will focus on the key components of the vehicles from the most commonly used topical therapies for papulopustular rosacea and how vehicle formulations influence the delivery of active ingredient, skin barrier repair, tolerability and compliance.
PRN 96-8: Toxicologically Significant Levels of Pesticide Active Ingredients
This notice sets out EPA's interpretation of the term toxicologically significant as it applies to contaminants in pesticide products that are also pesticide active ingredients. It provides risk-based concentration levels of such contaminants.
Active Pharmaceutical Ingredients and Aquatic Organisms
The presence of active pharmaceuticals ingredients (APIs) in aquatic systems in recent years has led to a burgeoning literature examining environmental occurrence, fate, effects, risk assessment, and treatability of these compounds. Although APIs have received much attention as ...
Federal Register 2010, 2011, 2012, 2013, 2014
2013-12-18
..., 2012, concerning a new active ingredient (AI). The name of an AI was changed during the registration assessment process. This document corrects the name of the AI. FOR FURTHER INFORMATION CONTACT: Robert...
Federal Register 2010, 2011, 2012, 2013, 2014
2012-09-26
...: Valent U.S.A. Corporation, P.O. Box 8025, Walnut Creek, CA 94596. Active ingredient: Clothianidin..., P.O. Box 8025, Walnut Creek, CA 94596. Active ingredient: Clothianidin. Product Type: Insecticide...
Nervous system active pharmaceutical ingredients (APIs), including anti-depressants and opioids, are important clinically administered pharmaceuticals within healthcare facilities. Concentrations and mass loadings of ten nervous system APIs and three nervous system API metaboli...
El-Far, Ali H; Badria, Faried A; Shaheen, Hazem M
2016-01-01
Costus speciosus is native to South East Asia, especially found in India, Srilanka, Indonesia and Malaysia. C. speciosus have numerous therapeutic potentials against a wide variety of complains. The therapeutic properties of C. speciosus are attributed to the presence of various ingredients such as alkaloids, flavonoids, glycosides, phenols, saponins, sterols and sesquiterpenes. This review presented the past, present, and the future status of C. speciosus active ingredients to propose a future use as a potential anticancer agent. All possible up-regulation of cellular apoptotic molecules as p53, p21, p27, caspases, reactive oxygen species (ROS) generation and others attribute to the anticancer activity of C. speciosus along the down-regulation of anti-apoptotic agents such as Akt, Bcl2, NFKB, STAT3, JAK, MMPs, actin, surviving and vimentin. Eventually, we recommend further investigation of different C. speciosus extracts, using some active ingredients and evaluate the anticancer effect of these chemicals against different cancers.
[Antitumor effect research progress of shikonin and its derivatives].
Zhu, Meng-Yuan; Wang, Ru-Bing; Zhou, Wen; Li, Shao-Shun
2012-05-01
Shikonin, the main active ingredient of Lithospermum, and its derivatives have been proved to have antitumor effects, and the anti-tumor mechanisms involve multiple targets. Based on recent literatures, this review focuses on the antitumor effects and its mechanisms. More emphases are given on the aspects of induction of apoptosis, induction of necrosis, acting on matrix metalloproteinase, acting on the protein tyrosine kinase and antiangiogenesis. The current status and problems of shikonin derivatives in antitumor effects are simply summarized and lookout for the development of antitumor drugs with shikonin as leading compounds.
Tao, Jin; Hou, Yuanyuan; Ma, Xiaoyao; Liu, Dan; Tong, Yongling; Zhou, Hong; Gao, Jie; Bai, Gang
2016-01-08
Traditional Chinese medicine (TCM) herbal formulae provide valuable therapeutic strategies. However, the active ingredients and mechanisms of action remain unclear for most of these formulae. Therefore, the identification of complex mechanisms is a major challenge in TCM research. This study used a network pharmacology approach to clarify the anti-inflammatory and cough suppressing mechanisms of the Chinese medicinal preparation Eriobotrya japonica - Fritillaria usuriensis dropping pills (ChuanbeiPipa dropping pills, CBPP). The chemical constituents of CBPP were identified by high-quality ultra-performance liquid chromatography/quadrupole time-of-flight mass spectrometry (UPLC/Q-TOF-MS), and anti-inflammatory ingredients were selected and analyzed using the PharmMapper and Kyoto Encyclopedia of Genes and Genomes (KEGG) bioinformatics websites to predict the target proteins and related pathways, respectively. Then, an RNA-sequencing (RNA-Seq) analysis was carried out to investigate the different expression of genes in the lung tissue of rats with chronic bronchitis. Six main constituents affected 19 predicted pathways, including ursolic acid and oleanolic acid from Eriobotrya japonica (Thunb.) Lindl. (Eri), peiminine from Fritillaria usuriensis Maxim. (Fri), platycodigenin and polygalacic acid from Platycodon grandiflorum (Jacq.) A. DC. (Pla) and guanosine from Pinellia ternata (Thunb.) Makino. (Pin). Expression of 34 genes was significantly decreased after CBPP treatment, affecting four therapeutic functions: immunoregulation, anti-inflammation, collagen formation and muscle contraction. The active components acted on the mitogen activated protein kinase (MAPK) pathway, transforming growth factor (TGF)-beta pathway, focal adhesion, tight junctions and the action cytoskeleton to exert anti-inflammatory effects, resolve phlegm, and relieve cough. This novel approach of global chemomics-integrated systems biology represents an effective and accurate strategy for the study of TCM with multiple components and multiple target mechanisms.
40 CFR 156.208 - Restricted-entry statements.
Code of Federal Regulations, 2013 CFR
2013-07-01
... interval” (or the letters “REI”). (c) Restricted-entry interval based on toxicity of active ingredient—(1... of the active ingredients in the product. For the purpose of setting the restricted-entry interval, the toxicity category of each active ingredient in the product shall be determined by comparing the...
40 CFR 156.208 - Restricted-entry statements.
Code of Federal Regulations, 2014 CFR
2014-07-01
... interval” (or the letters “REI”). (c) Restricted-entry interval based on toxicity of active ingredient—(1... of the active ingredients in the product. For the purpose of setting the restricted-entry interval, the toxicity category of each active ingredient in the product shall be determined by comparing the...
40 CFR 156.208 - Restricted-entry statements.
Code of Federal Regulations, 2012 CFR
2012-07-01
... interval” (or the letters “REI”). (c) Restricted-entry interval based on toxicity of active ingredient—(1... of the active ingredients in the product. For the purpose of setting the restricted-entry interval, the toxicity category of each active ingredient in the product shall be determined by comparing the...
40 CFR 156.208 - Restricted-entry statements.
Code of Federal Regulations, 2010 CFR
2010-07-01
... interval” (or the letters “REI”). (c) Restricted-entry interval based on toxicity of active ingredient—(1... of the active ingredients in the product. For the purpose of setting the restricted-entry interval, the toxicity category of each active ingredient in the product shall be determined by comparing the...
40 CFR 156.208 - Restricted-entry statements.
Code of Federal Regulations, 2011 CFR
2011-07-01
... interval” (or the letters “REI”). (c) Restricted-entry interval based on toxicity of active ingredient—(1... of the active ingredients in the product. For the purpose of setting the restricted-entry interval, the toxicity category of each active ingredient in the product shall be determined by comparing the...
Cloyd, Raymond A; Bethke, James A
2011-01-01
The neonicotinoid insecticides imidacloprid, acetamiprid, dinotefuran, thiamethoxam and clothianidin are commonly used in greenhouses and/or interiorscapes (plant interiorscapes and conservatories) to manage a wide range of plant-feeding insects such as aphids, mealybugs and whiteflies. However, these systemic insecticides may also be harmful to natural enemies, including predators and parasitoids. Predatory insects and mites may be adversely affected by neonicotinoid systemic insecticides when they: (1) feed on pollen, nectar or plant tissue contaminated with the active ingredient; (2) consume the active ingredient of neonicotinoid insecticides while ingesting plant fluids; (3) feed on hosts (prey) that have consumed leaves contaminated with the active ingredient. Parasitoids may be affected negatively by neonicotinoid insecticides because foliar, drench or granular applications may decrease host population levels so that there are not enough hosts to attack and thus sustain parasitoid populations. Furthermore, host quality may be unacceptable for egg laying by parasitoid females. In addition, female parasitoids that host feed may inadvertently ingest a lethal concentration of the active ingredient or a sublethal dose that inhibits foraging or egg laying. There are, however, issues that require further consideration, such as: the types of plant and flower that accumulate active ingredients, and the concentrations in which they are accumulated; the influence of flower age on the level of exposure of natural enemies to the active ingredient; the effect of neonicotinoid metabolites produced within the plant. As such, the application of neonicotinoid insecticides in conjunction with natural enemies in protected culture and interiorscape environments needs further investigation. Copyright © 2010 Society of Chemical Industry.
This action promulgates national emission standards for hazardous air pollutants (NESHAP) for the pesticide active ingredient (PAI) production source category under section 112 of the Clean Air Act as amended (CAA or Act).
Pesticide-exposure Matrix helps identify active ingredients in pesticides used in past years
Pesticide-exposure Matrix was developed to help epidemiologists and other researchers identify the active ingredients to which people were likely exposed when their homes and gardens were treated for pests in past years
Khan, Hira; Akhtar, Naveed; Ali, Atif; Khan, Haji M Shoaib; Sohail, Muhammad; Naeem, Muhammad; Nawaz, Zarqa
2016-09-01
Stability of hydrophilic and lipophilic vitamin C derivatives for quenching synergistic antioxidant activities and to treat oxidative related diseases is a major issue. This study was aimed to encapsulate hydrophilic and lipophilic vitamin C derivatives (ascorbyl palmitate and sodium ascorbyl phosphate) as functional ingredients in a newly formulated multiple emulsion of the W//W type to attain the synergistic antioxidant effects and the resultant system's long term physical and chemical stability. Several multiple emulsions using the same concentration of emulsifiers but different concentrations of ascorbyl palmitate and sodium ascorbyl phosphate were developed. Three finally selected multiple emulsions (ME₁, ME₂ and ME₃) were evaluated for physical stability in terms of rheology, microscopy, conductivity, pH, and organoleptic characteristics under different storage conditions for 3 months. Chemical stability was determined by HPLC on Sykam GmbH HPLC system (Germany), equipped with a variable UV detector. Results showed that at accelerated storage conditions all the three multiple emulsions had shear thinning behavior of varying shear stress with no influence of location of functional ingredients in a carrier system. Conductivity values increased and pH values remained within the skin pH range for 3 months. Microscopic analysis showed an increase in globule size with the passage of time, especially at higher temperatures while decreased at low temperatures. Centrifugation test did not cause phase separation till the 45th day, but little effects after 2 months. Chemical stability analysis by HPLC at the end of 3 months showed that ascorbyl palmitate and sodium ascorbyl phosphate were almost stable in all multiple emulsions with no influence of their location in a carrier system. Multiple emulsions were found a stable carrier for hydrophilic and lipophilic vitamin C derivatives to enhance their desired effects. Considering that many topical formulations contain simple vitamin C it is suggested that present study may contribute to the development of more stable formulations with a combination of vitamin C derivatives to enhance their cosmetic benefits.
Adwan, Ghaleb; Salameh, Yousef; Adwan, Kamel; Barakat, Ali
2012-05-01
To detect the anticandidal activity of nine toothpastes containing sodium fluoride, sodium monofluorophosphate and herbal extracts as an active ingredients against 45 oral and non oral Candida albicans (C. albicans) isolates. The antifungal activity of these toothpaste formulations was determined using a standard agar well diffusion method. Statistical analysis was performed using a statistical package, SPSS windows version 15, by applying mean values using one-way ANOVA with post-hoc least square differences (LSD) method. A P value of less than 0.05 was considered significant. All toothpastes studied in our experiments were effective in inhibiting the growth of all C. albicans isolates. The highest anticandidal activity was obtained from toothpaste that containing both herbal extracts and sodium fluoride as active ingredients, while the lowest activity was obtained from toothpaste containing sodium monofluorophosphate as an active ingredient. Antifungal activity of Parodontax toothpaste showed a significant difference (P< 0.001) against C. albicans isolates compared to toothpastes containing sodium fluoride or herbal products. In the present study, it has been demonstrated that toothpaste containing both herbal extracts and sodium fluoride as active ingredients are more effective in control of C. albicans, while toothpaste that containing monofluorophosphate as an active ingredient is less effective against C. albicans. Some herbal toothpaste formulations studied in our experiments, appear to be equally effective as the fluoride dental formulations and it can be used as an alternative to conventional formulations for individuals who have an interest in naturally-based products. Our results may provide invaluable information for dental professionals.
Adwan, Ghaleb; Salameh, Yousef; Adwan, Kamel; Barakat, Ali
2012-01-01
Objective To detect the anticandidal activity of nine toothpastes containing sodium fluoride, sodium monofluorophosphate and herbal extracts as an active ingredients against 45 oral and non oral Candida albicans (C. albicans) isolates. Methods The antifungal activity of these toothpaste formulations was determined using a standard agar well diffusion method. Statistical analysis was performed using a statistical package, SPSS windows version 15, by applying mean values using one-way ANOVA with post-hoc least square differences (LSD) method. A P value of less than 0.05 was considered significant. Results All toothpastes studied in our experiments were effective in inhibiting the growth of all C. albicans isolates. The highest anticandidal activity was obtained from toothpaste that containing both herbal extracts and sodium fluoride as active ingredients, while the lowest activity was obtained from toothpaste containing sodium monofluorophosphate as an active ingredient. Antifungal activity of Parodontax toothpaste showed a significant difference (P< 0.001) against C. albicans isolates compared to toothpastes containing sodium fluoride or herbal products. Conclusions In the present study, it has been demonstrated that toothpaste containing both herbal extracts and sodium fluoride as active ingredients are more effective in control of C. albicans, while toothpaste that containing monofluorophosphate as an active ingredient is less effective against C. albicans. Some herbal toothpaste formulations studied in our experiments, appear to be equally effective as the fluoride dental formulations and it can be used as an alternative to conventional formulations for individuals who have an interest in naturally-based products. Our results may provide invaluable information for dental professionals. PMID:23569933
Li, Peng; Chen, Jianxin; Zhang, Wuxia; Fu, Bangze; Wang, Wei
2017-01-04
Herbal medicine is a concoction of numerous chemical ingredients, and it exhibits polypharmacological effects to act on multiple pharmacological targets, regulating different biological mechanisms and treating a variety of diseases. Thus, this complexity is impossible to deconvolute by the reductionist method of extracting one active ingredient acting on one biological target. To dissect the polypharmacological effects of herbal medicines and their underling pharmacological targets as well as their corresponding active ingredients. We propose a system-biology strategy that combines omics and bioinformatical methodologies for exploring the polypharmacology of herbal mixtures. The myocardial ischemia model was induced by Ameroid constriction of the left anterior descending coronary in Ba-Ma miniature pigs. RNA-seq analysis was utilized to find the differential genes induced by myocardial ischemia in pigs treated with formula QSKL. A transcriptome-based inference method was used to find the landmark drugs with similar mechanisms to QSKL. Gene-level analysis of RNA-seq data in QSKL-treated cases versus control animals yields 279 differential genes. Transcriptome-based inference methods identified 80 landmark drugs that covered nearly all drug classes. Then, based on the landmark drugs, 155 potential pharmacological targets and 57 indications were identified for QSKL. Our results demonstrate the power of a combined approach for exploring the pharmacological target and chemical space of herbal medicines. We hope that our method could enhance our understanding of the molecular mechanisms of herbal systems and further accelerate the exploration of the value of traditional herbal medicine systems. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.
76 FR 5805 - Pesticide Products; Registration Applications
Federal Register 2010, 2011, 2012, 2013, 2014
2011-02-02
... Seed Treatment. Active ingredient: Plant growth regulator, Salicylic Acid, at 0.04%. Proposed... Treatment. Active ingredient: Plant growth regulator, Salicylic Acid, at 0.0067%. Proposed classification... Pyxis Consulting, Inc., 4110 136th St., NW., Gig Harbor, WA 98332. Product name: Salicylic Acid...
Ferreira, Anderson de Oliveira; Polonini, Hudson; da Silva, Sharlene Loures; Aglio, Natália Cristina Buzinari; Abreu, Jordana; Fernandes, Brandão Marcos Antônio
2017-01-01
The objective of this study was to evaluate the stability of 7 commonly used active pharmaceutical ingredients compounded in oral suspensions using an internationally used suspending vehicle (SyrSpend SF PH4): acetazolamide 25.0 mg/mL, baclofen 10.0 mg/mL, dipyridamole 10.0 mg/mL, mebeverine hydrochloride 10.0 mg/mL, propylthiouracil 5.0 mg/mL, quinidine sulfate 10.0 mg/mL, and topiramate 5.0 mg/mL. All suspensions were stored both at controlled refrigerated (2°C to 8°C) and room temperature (20°C to 25°C). Stability was assessed by measuring the percentage recovery at varying time points throughout a 90-day period. Active pharmaceutical ingredient quantification was performed by ultraviolet (UV) high-performance liquid chromatography, via a stability-indicating method. Given the percentage of recovery of the active pharmaceutical ingredients within the suspensions, the beyond-use date of the final products (active pharmaceutical ingredient + vehicle) was at least 90 days for all suspensions with regards to both temperatures. This suggests that SyrSpend SF PH4 is suitable for compounding active pharmaceutical ingredients from different pharmacological classes. Copyright© by International Journal of Pharmaceutical Compounding, Inc.
Suspensions as a Valuable Alternative to Extemporaneously Compounded Capsules.
Dijkers, Eli; Nanhekhan, Valerie; Thorissen, Astrid; Polonini, Hudson
2017-01-01
The objective of this study was to determine the variation in content of 74 different active pharmaceutical ingredients (APIs) and compare it with what is known in the literature for the content uniformity of extemporaneous prepared capsules. Active pharmaceutical ingredients quantification was performed by high-performance liquid chromatography, via a stability-indicating method. Samples for all active pharmaceutical ingredients were taken throughout a 90-day period and the content was determined. In total, 5,190 different samples were analyzed for 74 different active pharmaceutical ingredients at room (15°C to 25°C) or controlled refrigerated temperature (2°C to 8°C). Each of these datasets was analyzed according to the United States Pharmacopeia Content Uniformity monograph, corrected for the sample number. The mean acceptance values were well within specifications. In addition, all suspensions complied with the criteria defined by the British Pharmacopoeia monograph for Content Uniformity of Liquid Dispersions for both room and controlled refrigerated temperature. In previous studies, it was found that a routine weight variation check is often not sufficient for quality assurance of extemporaneous prepared capsules. Compounded oral liquids show little variation in content for 74 different active pharmaceutical ingredients; therefore, compounded oral liquids are a suitable alternative when compounding individualized medications for patients. Copyright© by International Journal of Pharmaceutical Compounding, Inc.
Suñer, Joaquim; Calpena, Ana C; Clares, Beatriz; Cañadas, Cristina; Halbaut, Lyda
2017-02-01
Multiple emulsions have attracted considerable attention in recent years for application as potential delivery systems for different drugs. The aim of the present work is to design a new formulation containing clotrimazole (CLT) loaded into multiple emulsions by two-step emulsification method for transdermal delivery. Different ingredients and quantities like primary and secondary co-emulsifiers and the nature of oily phase were assayed in order to optimize the best system for good. Resulting formulations were characterized in terms of droplet size, conductivity, pH, entrapment efficiency, rheological behavior, and stability under various storage conditions for 180 days. pH values of multiple emulsions containing CLT ranged from 7.04 ± 0.03 to 6.23 ± 0.04. Droplet size increased when increasing concentration of sorbitan stearate. The addition of polysorbate 80 resulted in significant decrease of oil droplet size comparing with those prepared without this. CLT entrapment efficiency ranged between 85.64% and 97.47%. All formulations exhibited non-Newtonian pseudoplastic flow with some apparent thixotropic behavior. Cross and Herschel-Bulkley equations were the models that best fitted experimental data. In general, the addition of 1% polysorbate 80 resulted in a decrease of viscosity values. No signals of optical instability were observed, and physicochemical properties remained almost constant when samples were stored at room temperature after 180 days. On the contrary, samples stored at 40°C exhibited pronounced increase in conductivity values 24 h after elaboration and some of them were unstable after 180 days of storage. JMLP01 was proposed as an innovative and stable system to incorporate CLT as active pharmaceutical ingredient.
21 CFR 333.160 - Labeling of permitted combinations of active ingredients.
Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Labeling of permitted combinations of active ingredients. 333.160 Section 333.160 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND... HUMAN USE First Aid Antibiotic Drug Products § 333.160 Labeling of permitted combinations of active...
21 CFR 333.160 - Labeling of permitted combinations of active ingredients.
Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Labeling of permitted combinations of active ingredients. 333.160 Section 333.160 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND... HUMAN USE First Aid Antibiotic Drug Products § 333.160 Labeling of permitted combinations of active...
21 CFR 333.160 - Labeling of permitted combinations of active ingredients.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Labeling of permitted combinations of active ingredients. 333.160 Section 333.160 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND... HUMAN USE First Aid Antibiotic Drug Products § 333.160 Labeling of permitted combinations of active...
21 CFR 207.25 - Information required in registration and drug listing.
Code of Federal Regulations, 2010 CFR
2010-04-01
...-2657 or in conjunction with the FDA voluntary inventory on Form FDA-2422 (Survey Report of Marketed... blood bank, a quantitative listing of the active ingredient(s). Unless the quantitative listing is...)(iii), the registrant may limit the quantitative listing of ingredients to each variation of level of...
21 CFR 207.25 - Information required in registration and drug listing.
Code of Federal Regulations, 2011 CFR
2011-04-01
...-2657 or in conjunction with the FDA voluntary inventory on Form FDA-2422 (Survey Report of Marketed... blood bank, a quantitative listing of the active ingredient(s). Unless the quantitative listing is...)(iii), the registrant may limit the quantitative listing of ingredients to each variation of level of...
21 CFR 207.25 - Information required in registration and drug listing.
Code of Federal Regulations, 2012 CFR
2012-04-01
...-2657 or in conjunction with the FDA voluntary inventory on Form FDA-2422 (Survey Report of Marketed... blood bank, a quantitative listing of the active ingredient(s). Unless the quantitative listing is...)(iii), the registrant may limit the quantitative listing of ingredients to each variation of level of...
21 CFR 207.25 - Information required in registration and drug listing.
Code of Federal Regulations, 2014 CFR
2014-04-01
...-2657 or in conjunction with the FDA voluntary inventory on Form FDA-2422 (Survey Report of Marketed... blood bank, a quantitative listing of the active ingredient(s). Unless the quantitative listing is...)(iii), the registrant may limit the quantitative listing of ingredients to each variation of level of...
21 CFR 207.25 - Information required in registration and drug listing.
Code of Federal Regulations, 2013 CFR
2013-04-01
...-2657 or in conjunction with the FDA voluntary inventory on Form FDA-2422 (Survey Report of Marketed... blood bank, a quantitative listing of the active ingredient(s). Unless the quantitative listing is...)(iii), the registrant may limit the quantitative listing of ingredients to each variation of level of...
Du, Ran-Feng; Zhang, Xiao-Hua; Ye, Xiao-Tong; Yu, Wen-Kang; Wang, Yun
2016-07-01
Dampness evil is the source of all diseases, which is easy to cause disease and promote aging, while aging could also promote the occurence and development of diseases. In this paper, the relationship between the dampness evil and aging would be discussed, to find the anti-aging active ingredients in traditional Chinese medicine (TCM), and analyze the anti-aging mechanism of dampness eliminating drug. Molecular docking technology was used, with aging-related mammalian target of rapamycin as the docking receptors, and chemical components of Fuling, Sangzhi, Mugua, Yiyiren and Houpo as the docking molecules, to preliminarily screen the anti-aging active ingredients in dampness eliminating drug. Through the comparison with active drugs already on the market (temsirolimus and everolimus), 12 kinds of potential anti-aging active ingredients were found, but their drug gability still needs further study. The docking results showed that various components in the dampness eliminating drug can play anti-aging activities by acting on mammalian target of rapamycin. This result provides a new thought and direction for the method of delaying aging by eliminating dampness. Copyright© by the Chinese Pharmaceutical Association.
Huang, Yinghong; Cai, Tiange; Xia, Xi; Cai, Y; Wu, Xiao Yu
2016-01-01
A large body of evidence has shown that inflammation and cancer are strongly related. Thus anti-inflammatory agents have been investigated for cancer prevention and treatment in preclinical and clinical studies, including the nonsteroidal anti-inflammatory drugs (NSAIDs) and traditional Chinese medicine (TCM). In TCM, there exist a wide range of biologically active substances, such as saponins, flavonoids, alkaloids, polysaccharides, polyphenols, phenylpropanoids, and quinones. Many of these active ingredients have been reported to inhibit inflammation, activate inflammatory immune response, and/or inhibit cancer cell proliferation and tumor growth. Given the potential role of inflammation in cancer initiation and progression, the inflammatory tumor microenvironment, the cross-talks between inflammatory and cancer cells, and multitargeting activities of some TCM compounds, we summarize the current knowledge on the anti-inflammatory and anti-cancer properties of ingredients of TCM together with their underlying mechanisms in an integrated way. We hope to provide a reliable basis and useful information for the development of new treatment strategies of inflammation and cancer comprehensively using TCM and their active ingredients.
75 FR 4384 - Pesticide Products; Registration Applications
Federal Register 2010, 2011, 2012, 2013, 2014
2010-01-27
... Park, NC 27709. Product name: Indaziflam 500 SC Herbicide. Active ingredient: Herbicide with Indaziflam.... Alexander Drive, Research Triangle Park, NC 27709. Product name: Indaziflam 200 SC Herbicide. Active ingredient: Herbicide with Indaziflam at 19.05%. Proposed use: Preemergent control of annual [[Page 4386...
SENSITIVE SUBPOPULATIONS AND CHILDREN'S HEALTH
There are over 20,000 pesticide products containing 620 active ingredients on the market. Each year, 1 billion pounds of active ingredients in conventional pesticides are applied in the United States. There are over 80,000 existing chemicals on the TSCA inventory and each year an...
Characterization Methods of Encapsulates
NASA Astrophysics Data System (ADS)
Zhang, Zhibing; Law, Daniel; Lian, Guoping
Food active ingredients can be encapsulated by different processes, including spray drying, spray cooling, spray chilling, spinning disc and centrifugal co-extrusion, extrusion, fluidized bed coating and coacervation (see Chap. 2 of this book). The purpose of encapsulation is often to stabilize an active ingredient, control its release rate and/or convert a liquid formulation into a solid which is easier to handle. A range of edible materials can be used as shell materials of encapsulates, including polysaccharides, fats, waxes and proteins (see Chap. 3 of this book). Encapsulates for typical industrial applications can vary from several microns to several millimetres in diameter although there is an increasing interest in preparing nano-encapsulates. Encapsulates are basically particles with a core-shell structure, but some of them can have a more complex structure, e.g. in a form of multiple cores embedded in a matrix. Particles have physical, mechanical and structural properties, including particle size, size distribution, morphology, surface charge, wall thickness, mechanical strength, glass transition temperature, degree of crystallinity, flowability and permeability. Information about the properties of encapsulates is very important to understanding their behaviours in different environments, including their manufacturing processes and end-user applications. E.g. encapsulates for most industrial applications should have desirable mechanical strength, which should be strong enough to withstand various mechanical forces generated in manufacturing processes, such as mixing, pumping, extrusion, etc., and may be required to be weak enough in order to release the encapsulated active ingredients by mechanical forces at their end-user applications, such as release rate of flavour by chewing. The mechanical strength of encapsulates and release rate of their food actives are related to their size, morphology, wall thickness, chemical composition, structure etc. Hence, reliable methods which can be used to characterize these properties of encapsulates are vital. In this chapter, the state-of-art of these methods, their principles and applications, and release mechanisms are described as follows.
Wu, Qing-Qing; Chen, Yan; Xin, Ran; Wang, Jin-Yan; Zhou, Lei; Yuan, Ling; Jia, Xiao-Bin
2012-05-01
The aim of this study is to investigate the rat intestinal absorption behavior of two main active components, liquiritin, glycyrrhizin and the extract of Glycyrrhiza uralensis. The rat intestinal perfusion model was employed. Concentrations of the compounds of the interest in the intestinal perfusate, bile and plasma samples were determined by HPLC and UPLC. At the same time, the intestinal enzymes incubation test and the partition coefficient determination, the absorption of liquiritin and glycyrrhizin alone and the extract were multiple analyzed. The results showed that the P(eff) (effective permeability) of liquiritin or glycyrrhizin alone or the extract was less than 0.3, which suggested their poor absorption in the intestine. The P(eff) of the two main active components or the extract was not significantly different in duodenum, jejunum, colon and ileum segment. The P(eff) of the glycyrrhizin in the extract had no significant difference in the four intestinal segments compared with the glycyrrhizin alone. The absorption of the liquiritin displayed significant difference (P < 0.05) at ileum segment compared with the liquiritin alone, while it had no markedly change in the other three segments. This phenomenon indicated that some ingredients in the extract might improve the absorption of liquiritin. Moreover, no parent compounds and their metabolites were found in the intestinal perfusate, bile and the plasma samples. The results demonstrated that the influence of the other ingredients in the extract on the two components might not increase the amount of liquiritin and glycyrrhizin in the bile and plasma within the duration of the test.
Kondratiuk, Mykola; Blagaia, Anna; Pelo, Ihor
2018-01-01
Introduction: The quality of the air environment significantly affects the health of the population. Chemical plant protection products in the spring and summer time may be the main pollutants of the air environment in rural areas. Chemical plant protection products are dangerous substances of anthropogenic origin. If applying pesticides in high concentrations, the risk of poisoning by active ingredients of pesticide preparations in workers directly contacting with it increases. The aim: Comparative hygienic assessment of active ingredients content in the air environment after treatment of cereal spiked crops by combined fungicides was the aim of the work. Materials and methods: Active ingredients of the studied combined fungicides, samples of air, and swabs from workers' skin and stripes from overalls were materials of the research. Methods of full-scale in-field hygienic experiment, gas-liquid chromatography, high-performance liquid chromatography, as well as statistical and bibliographic methods were used in the research. Results and conclusions: Active ingredients of the studied combined fungicides were not detected in the working zone air and atmospheric air at the levels exceeding the limits of its detection by appropriate chromatography methods. Findings confirmed the air environment safety for agricultural workers and rural population if studied combined fungicides are applied following the hygienically approved suggested application rates and in accordance of good agricultural practice rules. However the possible complex risk for workers after certain studied fungicides application may be higher than acceptable due to the elevated values for dermal effects. The complex risk was higher than acceptable in еру case of aerial spraying of both studied fungicides, meanwhile only one combination of active ingredients revealed possible risk for workers applying fungicides by rod method of cereal spiked crops treatment.
Combination Chemoprevention with Grape Antioxidants
Singh, Chandra K.; Siddiqui, Imtiaz A.; El-Abd, Sabah; Mukhtar, Hasan; Ahmad, Nihal
2016-01-01
Antioxidant ingredients present in grape have been extensively investigated for their cancer chemopreventive effects. However, much of the work has been done on individual ingredients, especially focusing on resveratrol and quercetin. Phytochemically, whole grape represents a combination of numerous phytonutrients. Limited research has been done on the possible synergistic/additive/antagonistic interactions among the grape constituents. Among these phytochemical constituents of grapes, resveratrol, quercetin, kaempferol, catechin, epicatechin, and anthocyanins (cyanidin and malvidin) constitute more than 70% of the grape polyphenols. Therefore, these have been relatively well-studied for their chemopreventive effects against a variety of cancers. While a wealth of information is available individually on cancer chemopreventive/anti-proliferative effects of resveratrol and quercetin, limited information is available regarding the other major constituents of grape. Studies have also suggested that multiple grape antioxidants, when used in combination, alone or with other agents/drugs show synergistic or additive anti-proliferative response. Based on strong rationale emanating from published studies, it seems probable that a combination of multiple grape-ingredients alone or together with other agents could impart ‘additive synergism’ against cancer. PMID:26829056
Combination chemoprevention with grape antioxidants.
Singh, Chandra K; Siddiqui, Imtiaz A; El-Abd, Sabah; Mukhtar, Hasan; Ahmad, Nihal
2016-06-01
Antioxidant ingredients present in grape have been extensively investigated for their cancer chemopreventive effects. However, much of the work has been done on individual ingredients, especially focusing on resveratrol and quercetin. Phytochemically, whole grape represents a combination of numerous phytonutrients. Limited research has been done on the possible synergistic/additive/antagonistic interactions among the grape constituents. Among these phytochemical constituents of grapes, resveratrol, quercetin, kaempferol, catechin, epicatechin, and anthocyanins (cyanidin and malvidin) constitute more than 70% of the grape polyphenols. Therefore, these have been relatively well studied for their chemopreventive effects against a variety of cancers. While a wealth of information is available individually on cancer chemopreventive/anti-proliferative effects of resveratrol and quercetin, limited information is available regarding the other major constituents of grape. Studies have also suggested that multiple grape antioxidants, when used in combination, alone or with other agents/drugs show synergistic or additive anti-proliferative response. Based on strong rationale emanating from published studies, it seems probable that a combination of multiple grape ingredients alone or together with other agents could impart 'additive synergism' against cancer. © 2016 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.
Naturally derived anti-inflammatory compounds from Chinese medicinal plants.
Wang, Qiuhong; Kuang, Haixue; Su, Yang; Sun, Yanping; Feng, Jian; Guo, Rui; Chan, Kelvin
2013-03-07
Though inflammatory response is beneficial to body damage repair, if it is out of control, it can produce adverse effects on the body. Although purely western anti-inflammatory drugs, orthodox medicines, can control inflammation occurrence and development, it is not enough. The clinical efficacy of anti-inflammation therapies is unsatisfactory, thus the search for new anti-inflammation continues. Chinese Material Medica (CMM) remains a promising source of new therapeutic agents. CMM and herbal formulae from Traditional Chinese Medicine (TCM), unorthodox medicines, play an improtant anti-inflammatory role in multi-targets, multi-levels, and multi-ways in treating inflammation diseases in a long history in China, based on their multi-active ingredient characteristics. Due to these reasons, recently, CMM has been commercialized as an anti-inflammation agent which has become increasingly popular in the world health drug markets. Major research contributions in ethnopharmacology have generated vast amount of data associated with CMM in anti-inflammtion aspect. Therefore, a systematic introduction of CMM anti-inflammatory research progress is of great importance and necessity. This paper strives to describe the progress of CMM in the treatment of inflammatory diseases from different aspects, and provide the essential theoretical support and scientific evidence for the further development and utilization of CMM resources as a potential anti-inflammation drug through a variety of databases. Literature survey was performed via electronic search (SciFinder®, Pubmed®, Google Scholar and Web of Science) on papers and patents and by systematic research in ethnopharmacological literature at various university libraries. This review mainly introduced the current research on the anti-inflammatory active ingredient, anti-inflammatory effects of CMM, their mechanism, anti-inflammatory drug development of CMM, and toxicological information. CMM is used clinically to treat inflammation symptoms in TCM, and its effect is mediated by multiple targets through multiple active ingredients. Although scholars around the world have made studies on the anti-inflammatory studies of CMM from different pathways and aspects and have made substantial progress, further studies are warranted to delineate the inflammation actions in more cogency models, establish the toxicological profiles and quality standards, assess the potentials of CMM in clinical applications, and make more convenient preparations easy to administrate for patients. Development of the clinically anti-inflammatory drugs are also warranted. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.
Patient, Physician and Organizational Influences on Variation in Antipsychotic Prescribing Behavior.
Tang, Yan; Chang, Chung-Chou H; Lave, Judith R; Gellad, Walid F; Huskamp, Haiden A; Donohue, Julie M
2016-03-01
Physicians face the choice of multiple ingredients when prescribing drugs in many therapeutic categories. For conditions with considerable patient heterogeneity in treatment response, customizing treatment to individual patient needs and preferences may improve outcomes. To assess variation in the diversity of antipsychotic prescribing for mental health conditions, a necessary although not sufficient condition for personalizing treatment. To identify patient caseload, physician, and organizational factors associated with the diversity of antipsychotic prescribing. Using 2011 data from Pennsylvania's Medicaid program, IMS Health's HCOSTM database, and the AMA Masterfile, we identified 764 psychiatrists who prescribed antipsychotics to 10 patients. We constructed three physician-level measures of diversity/concentration of antipsychotic prescribing: number of ingredients prescribed, share of prescriptions for most preferred ingredient, and Herfindahl-Hirschman index (HHI). We used multiple membership linear mixed models to examine patient caseload, physician, and healthcare organizational predictors of physician concentration of antipsychotic prescribing. There was substantial variability in antipsychotic prescribing concentration among psychiatrists, with number of ingredients ranging from 2-17, share for most preferred ingredient from 16%-85%, and HHI from 1,088-7,270. On average, psychiatrist prescribing behavior was relatively diversified; however, 11% of psychiatrists wrote an average of 55% of their prescriptions for their most preferred ingredient. Female prescribers and those with smaller shares of disabled or serious mental illness patients had more concentrated prescribing behavior on average. Antipsychotic prescribing by individual psychiatrists in a large state Medicaid program varied substantially across psychiatrists. Our findings illustrate the importance of understanding physicians' prescribing behavior and indicate that even among specialties regularly prescribing a therapeutic category, some physicians rely heavily on a small number of agents. Health systems may need to offer educational interventions to clinicians in order to improve their ability to tailor treatment decisions to the needs of individual patients. Future studies should examine the impact of the diversity of antipsychotic prescribing to determine whether more diversified prescribing improves patient adherence and outcomes.
Evaluation of the relative risk to birds of alternative pesticides using EPA’s TIM/MCnest Model
Agricultural producers today have many choices of active ingredients for crop protection. These products come with different active ingredients, different modes of action, and that initiate different adverse outcome pathways. Use patterns also differ considerably among products...
Code of Federal Regulations, 2010 CFR
2010-07-01
.... Establishment means any site where a pesticidal product, active ingredient, or device is produced, regardless of... formulation: (1) Is corrosive to the container; (2) Causes softening, premature aging, or embrittlement of the... the active ingredient permeating the container wall, that would cause the formulation to differ from...
Code of Federal Regulations, 2012 CFR
2012-07-01
... 40 Protection of Environment 31 2012-07-01 2012-07-01 false Organic Pesticide Active Ingredient New Source Performance Standards (NSPS) and Pretreatment Standards for New Sources (PSNS) 3 Table 3 to... STANDARDS (CONTINUED) PESTICIDE CHEMICALS Pt. 455, Table 3 Table 3 to Part 455—Organic Pesticide Active...
USDA-ARS?s Scientific Manuscript database
The determination of nutrient digestibility’s in specific ingredients and diets for fish has been an area of active research for decades. The Apparent Digestibility Coefficients (ADC), the percentage of nutrients in an ingredient that are available to the fish, is information needed by researchers,...
HIM-herbal ingredients in-vivo metabolism database.
Kang, Hong; Tang, Kailin; Liu, Qi; Sun, Yi; Huang, Qi; Zhu, Ruixin; Gao, Jun; Zhang, Duanfeng; Huang, Chenggang; Cao, Zhiwei
2013-05-31
Herbal medicine has long been viewed as a valuable asset for potential new drug discovery and herbal ingredients' metabolites, especially the in vivo metabolites were often found to gain better pharmacological, pharmacokinetic and even better safety profiles compared to their parent compounds. However, these herbal metabolite information is still scattered and waiting to be collected. HIM database manually collected so far the most comprehensive available in-vivo metabolism information for herbal active ingredients, as well as their corresponding bioactivity, organs and/or tissues distribution, toxicity, ADME and the clinical research profile. Currently HIM contains 361 ingredients and 1104 corresponding in-vivo metabolites from 673 reputable herbs. Tools of structural similarity, substructure search and Lipinski's Rule of Five are also provided. Various links were made to PubChem, PubMed, TCM-ID (Traditional Chinese Medicine Information database) and HIT (Herbal ingredients' targets databases). A curated database HIM is set up for the in vivo metabolites information of the active ingredients for Chinese herbs, together with their corresponding bioactivity, toxicity and ADME profile. HIM is freely accessible to academic researchers at http://www.bioinformatics.org.cn/.
40 CFR 161.155 - Product composition.
Code of Federal Regulations, 2010 CFR
2010-07-01
... REQUIREMENTS FOR REGISTRATION OF ANTIMICROBIAL PESTICIDES Product Chemistry Data Requirements § 161.155 Product...-registered product: (i) The chemical and common name (if any) of the active ingredient, as listed on the... active ingredient in the product is not an EPA-registered product: (i) The chemical name according to...
40 CFR 161.155 - Product composition.
Code of Federal Regulations, 2012 CFR
2012-07-01
... REQUIREMENTS FOR REGISTRATION OF ANTIMICROBIAL PESTICIDES Product Chemistry Data Requirements § 161.155 Product...-registered product: (i) The chemical and common name (if any) of the active ingredient, as listed on the... active ingredient in the product is not an EPA-registered product: (i) The chemical name according to...
40 CFR 180.1150 - 6-Benzyladenine; exemption from the requirement of a tolerance.
Code of Federal Regulations, 2014 CFR
2014-07-01
... apple and pear when applied at a rate of ≤182 grams of active ingredient per acre per season, and in or on pistachio when applied at a rate of ≤60 grams of active ingredient per acre per season. [72 FR...
40 CFR 180.1150 - 6-Benzyladenine; exemption from the requirement of a tolerance.
Code of Federal Regulations, 2012 CFR
2012-07-01
... apple and pear when applied at a rate of ≤182 grams of active ingredient per acre per season, and in or on pistachio when applied at a rate of ≤60 grams of active ingredient per acre per season. [72 FR...
40 CFR 180.1150 - 6-Benzyladenine; exemption from the requirement of a tolerance.
Code of Federal Regulations, 2013 CFR
2013-07-01
... apple and pear when applied at a rate of ≤182 grams of active ingredient per acre per season, and in or on pistachio when applied at a rate of ≤60 grams of active ingredient per acre per season. [72 FR...
40 CFR 180.1150 - 6-Benzyladenine; exemption from the requirement of a tolerance.
Code of Federal Regulations, 2010 CFR
2010-07-01
... apple and pear when applied at a rate of ≤182 grams of active ingredient per acre per season, and in or on pistachio when applied at a rate of ≤60 grams of active ingredient per acre per season. [72 FR...
40 CFR 180.1150 - 6-Benzyladenine; exemption from the requirement of a tolerance.
Code of Federal Regulations, 2011 CFR
2011-07-01
... apple and pear when applied at a rate of ≤182 grams of active ingredient per acre per season, and in or on pistachio when applied at a rate of ≤60 grams of active ingredient per acre per season. [72 FR...
21 CFR 514.106 - Approval of supplemental applications.
Code of Federal Regulations, 2010 CFR
2010-04-01
..., storage, expiration dates, etc). (vi) A change in promotional material for a prescription new animal drug... application. Category II supplements include the following: (i) A change in the active ingredient... specifications of the active or inactive ingredients. (iii) A change in dose (amount of drug administered per...
21 CFR 514.106 - Approval of supplemental applications.
Code of Federal Regulations, 2011 CFR
2011-04-01
..., storage, expiration dates, etc). (vi) A change in promotional material for a prescription new animal drug... application. Category II supplements include the following: (i) A change in the active ingredient... specifications of the active or inactive ingredients. (iii) A change in dose (amount of drug administered per...
78 FR 59347 - Pesticides; Revised Fee Schedule for Registration Applications
Federal Register 2010, 2011, 2012, 2013, 2014
2013-09-26
... active ingredients previously combined in other registered products; requires review of data package... data package within RD only; includes data and/or waivers of data for only: product chemistry and/or... source of active ingredient; submission of completely new generic data package; registered uses only...
Ferreira, Anderson O; Polonini, Hudson C; Loures da Silva, Sharlene; Cerqueira de Melo, Victor Augusto; de Andrade, Laura; Brandão, Marcos Antônio Fernandes
2017-01-01
The objective of this study was to evaluate the stability of 10 commonly used active pharmaceutical ingredients compounded in oral suspensions using an internationally used suspending vehicle (SyrSpend SF PH4): alprazolam 1.0 mg/mL, atropine sulfate 0.1 mg/mL, glutamine 250.0 mg/mL, levofloxacin 50.0 mg/mL, metoprolol tartrate 10.0 mg/mL, nitrofurantoin 2.0 mg/mL, ondansetron hydrochloride 0.8 mg/mL, oxandrolone 3.0 mg/mL, pregabaline 20.0 mg/mL, riboflavin 10.0 mg/mL. All suspensions were stored at both controlled refrigeration (2°C to 8°C) and controlled room temperature (20°C to 25°C). Stability was assessed by measuring the percent recovery at varying time points throughout a 90-day period. Active pharmaceutical ingredients quantification was performed by high-performance liquid chromatography via a stability-indicating method. Given the percentage of recovery of the active pharmaceutical ingredients within the suspensions, the beyond-use date of the final products (active pharmaceutical ingredients + vehicle) was at least 90 days for all suspensions with regard to both temperatures. This suggests that the vehicle is stable for compounding active pharmaceutical ingredients from different pharmacological classes. Copyright© by International Journal of Pharmaceutical Compounding, Inc.
Su, Xin-Yao; Xue, Jian-Ping; Wang, Cai-Xia
2016-11-01
The functional ingredients in Chinese materia medica are the main active substance for traditional Chinese medicine and most of them are secondary metabolites derivatives. Until now,the main method to obtain those functional ingredients is through direct extraction from the Chinese materia medica. However, the income is very low because of the high extraction costs and the decreased medicinal plants. Synthetic biology technology, as a new and microbial approach, can be able to carry out large-scale production of functional ingredients and greatly ease the shortage of traditional Chinese medicine ingredients. This review mainly focused on the recent advances in synthetic biology for the functional ingredients production. Copyright© by the Chinese Pharmaceutical Association.
Galgut, Jyoti M; Ali, Sharique A
2011-10-01
The present work was carried out to determine the effects of ethanolic extracts of Arachis hypogaea and its active ingredient resveratrol on the isolated tail melanophores of the Bufo melanostictus to find the mechanism of skin lightening at the cellular level. The tail melanophores of the tadpole B. melanostictus were assayed using the mean melanophore size index and their responses were recorded in presence of various concentrations of the plant extract and its active ingredient along with specific antagonists and potentiator. Significant skin lightening activity of the extract of A. hypogaea and its active ingredient resveratrol was observed on the tail melanophores of tadpole. The pigment cells responded by distinct aggregation leading to skin lightening, this effect was reversible, as re-immersion in physiological saline made the melanophores return to their normal intermediate state. These melanin aggregating effects were completely blocked by propanolol (beta blocker) and partially blocked by prazosin (alpha blocker) and were also found to be highly potentiated by reserpine. These studies suggest that the active ingredient of A. hypogaea such as resveratrol can act as a sympathomimetic compound and induce aggregation of melanophores of tadpole B. melanostictus via the induction of beta type of the adrenoceptors. The present study opens new vistas for the use of A. hypogaea and its active ingredient, resveratrol for its clinical application as a nontoxic melanolytic compound for the treatment of hyperpigmentation.
Arrhythmogenicity of weight-loss supplements marketed on the Internet.
Nazeri, Alireza; Massumi, Ali; Wilson, James M; Frank, Christopher M; Bensler, Michael; Cheng, Jie; Saeed, Mohammad; Rasekh, Abdi; Razavi, Mehdi
2009-05-01
We examined nonprescription weight-loss supplements marketed on the Internet for ingredients with potential arrhythmogenic and life-threatening cardiac adverse effects. We aimed to define the risks of life-threatening cardiac adverse effects that are associated with weight-loss supplements marketed on the Internet. We entered the key words "weight-loss supplements" and "diet pills" into three popular Internet search engines. The top four nonoverlapping hits from each search engine were purchased. After receipt, the products and their ingredient lists were inspected, and Medline and the Natural Medicines Comprehensive Database were searched for reports of significant associations between each ingredient and various key words for life-threatening cardiac adverse effects. All supplements had the list of ingredients on the label. We identified 60 different ingredients (7.25 +/- 4.66 per supplement; range 1-21). Eleven ingredients representing eight different substances (because multiple names were used for some substances) were each associated with two or more reports of life-threatening cardiac complications or death. Eight of the 12 products contained one or more such ingredients, but none of these eight products had warnings about life-threatening cardiac adverse effects on the Web pages, on the labels, or in the package inserts. One product contained ma huang (Chinese ephedra), even though the marketing of ephedra-containing products is banned in the United States. The Internet provides easy access to weight-loss supplements, several of which contain ingredients with potentially life-threatening adverse effects. There is a need for increased public education and awareness regarding such weight-loss products.
21 CFR 355.20 - Packaging conditions.
Code of Federal Regulations, 2011 CFR
2011-04-01
... HUMAN USE ANTICARIES DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 355.20 Packaging conditions. (a) Package size limitation. Due to the toxicity associated with fluoride active ingredients, the... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Packaging conditions. 355.20 Section 355.20 Food...
21 CFR 341.14 - Antitussive active ingredients.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Antitussive active ingredients. 341.14 Section 341.14 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE COLD, COUGH, ALLERGY, BRONCHODILATOR, AND ANTIASTHMATIC DRUG PRODUCTS FOR OVER-THE...
21 CFR 341.20 - Nasal decongestant active ingredients.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Nasal decongestant active ingredients. 341.20 Section 341.20 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE COLD, COUGH, ALLERGY, BRONCHODILATOR, AND ANTIASTHMATIC DRUG PRODUCTS FOR...
21 CFR 341.12 - Antihistamine active ingredients.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Antihistamine active ingredients. 341.12 Section 341.12 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE COLD, COUGH, ALLERGY, BRONCHODILATOR, AND ANTIASTHMATIC DRUG PRODUCTS FOR OVER-THE...
21 CFR 341.18 - Expectorant active ingredient.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Expectorant active ingredient. 341.18 Section 341.18 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE COLD, COUGH, ALLERGY, BRONCHODILATOR, AND ANTIASTHMATIC DRUG PRODUCTS FOR OVER-THE...
21 CFR 341.16 - Bronchodilator active ingredients.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Bronchodilator active ingredients. 341.16 Section 341.16 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE COLD, COUGH, ALLERGY, BRONCHODILATOR, AND ANTIASTHMATIC DRUG PRODUCTS FOR OVER-THE...
Medicines in My Home: Information for Students on the Safe Use of Over-the-Counter Medicines
... are safer when you follow directions. The active ingredients in OTC medicines can be harmful if you don’t use them as directed on the label. Take for example, the active ingredients in OTC fever and pain medicines.... • Acetaminophen can ...
40 CFR 152.403 - Definitions of fee categories.
Code of Federal Regulations, 2014 CFR
2014-07-01
... small-scale field testing of microbial pest control agents (40 CFR 172.3). [53 FR 19114, May 26, 1988... categories. (a) New chemical registration review means review of an application for registration of a pesticide product containing a chemical active ingredient which is not contained as an active ingredient in...
40 CFR 152.403 - Definitions of fee categories.
Code of Federal Regulations, 2010 CFR
2010-07-01
... small-scale field testing of microbial pest control agents (40 CFR 172.3). [53 FR 19114, May 26, 1988... categories. (a) New chemical registration review means review of an application for registration of a pesticide product containing a chemical active ingredient which is not contained as an active ingredient in...
40 CFR 152.403 - Definitions of fee categories.
Code of Federal Regulations, 2013 CFR
2013-07-01
... small-scale field testing of microbial pest control agents (40 CFR 172.3). [53 FR 19114, May 26, 1988... categories. (a) New chemical registration review means review of an application for registration of a pesticide product containing a chemical active ingredient which is not contained as an active ingredient in...
40 CFR 152.403 - Definitions of fee categories.
Code of Federal Regulations, 2011 CFR
2011-07-01
... small-scale field testing of microbial pest control agents (40 CFR 172.3). [53 FR 19114, May 26, 1988... categories. (a) New chemical registration review means review of an application for registration of a pesticide product containing a chemical active ingredient which is not contained as an active ingredient in...
40 CFR 152.403 - Definitions of fee categories.
Code of Federal Regulations, 2012 CFR
2012-07-01
... small-scale field testing of microbial pest control agents (40 CFR 172.3). [53 FR 19114, May 26, 1988... categories. (a) New chemical registration review means review of an application for registration of a pesticide product containing a chemical active ingredient which is not contained as an active ingredient in...
21 CFR 331.11 - Listing of specific active ingredients.
Code of Federal Regulations, 2013 CFR
2013-04-01
... contributing at least 25 percent of the total acid neutralizing capacity; maximum daily dosage limit is 8 grams...., 8 grams calcium carbonate). (e) Citrate-containing active ingredients: Citrate ion, as citric acid or salt; maximum daily dosage limit 8 grams. (f) Glycine (aminoacetic acid). (g) Magnesium-containing...
40 CFR 180.950 - Tolerance exemptions for minimal risk active and inert ingredients.
Code of Federal Regulations, 2013 CFR
2013-07-01
... AGENCY (CONTINUED) PESTICIDE PROGRAMS TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES IN FOOD... inert or an active ingredient in a pesticide chemical formulation, including antimicrobial pesticide..., cloves, and red pepper. (iii) Herbs such as basil, anise, or fenugreek. (2) Excluded from the term...
40 CFR 180.950 - Tolerance exemptions for minimal risk active and inert ingredients.
Code of Federal Regulations, 2011 CFR
2011-07-01
... AGENCY (CONTINUED) PESTICIDE PROGRAMS TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES IN FOOD... inert or an active ingredient in a pesticide chemical formulation, including antimicrobial pesticide..., cloves, and red pepper. (iii) Herbs such as basil, anise, or fenugreek. (2) Excluded from the term...
40 CFR 180.950 - Tolerance exemptions for minimal risk active and inert ingredients.
Code of Federal Regulations, 2012 CFR
2012-07-01
... AGENCY (CONTINUED) PESTICIDE PROGRAMS TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES IN FOOD... inert or an active ingredient in a pesticide chemical formulation, including antimicrobial pesticide..., cloves, and red pepper. (iii) Herbs such as basil, anise, or fenugreek. (2) Excluded from the term...
40 CFR 180.950 - Tolerance exemptions for minimal risk active and inert ingredients.
Code of Federal Regulations, 2014 CFR
2014-07-01
... AGENCY (CONTINUED) PESTICIDE PROGRAMS TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES IN FOOD... inert or an active ingredient in a pesticide chemical formulation, including antimicrobial pesticide..., cloves, and red pepper. (iii) Herbs such as basil, anise, or fenugreek. (2) Excluded from the term...
77 FR 8861 - Pesticide Products; Receipt of Applications To Register New Uses
Federal Register 2010, 2011, 2012, 2013, 2014
2012-02-15
... Protection, LLC, P.O. Box 18300, Greensboro, NC 27419. Active ingredient: Difenoconazole. Proposed Uses...: EPA- HQ-OPP-2011-0086. Company name and address: Syngenta Crop Protection, LLC, P.O. Box 18300... Protection, LLC, P.O. Box 18300, Greensboro, NC 27419. Active ingredient: Difenoconazole and Propiconazole...
Federal Register 2010, 2011, 2012, 2013, 2014
2012-05-11
... products containing specified active ingredients and marketed without approved applications. It also amends... certain OTC sunscreen products containing specified active ingredients and marketed without approved... risk of skin cancer and early skin aging caused by the sun. If the timeline for implementation...
Federal Register 2010, 2011, 2012, 2013, 2014
2010-03-02
... competitive with cGMP intermediates and Active Pharmaceutical Ingredients from the subject facility to a..., Conshohocken, Pennsylvania, who are engaged in employment related to the production of cGMP intermediates and...GMP intermediates and Active Pharmaceutical Ingredients, who became totally or partially separated...
Code of Federal Regulations, 2011 CFR
2011-04-01
... established in the statement of identity sections of the applicable OTC drug monographs. (1) Combinations of... ingredient in the directions sections of the applicable OTC drug monographs, unless otherwise stated in this... established for any individual ingredient in the applicable OTC drug monograph(s), and may not provide for use...
Code of Federal Regulations, 2010 CFR
2010-04-01
... established in the statement of identity sections of the applicable OTC drug monographs. (1) Combinations of... ingredient in the directions sections of the applicable OTC drug monographs, unless otherwise stated in this... established for any individual ingredient in the applicable OTC drug monograph(s), and may not provide for use...
Code of Federal Regulations, 2013 CFR
2013-07-01
... 40 Protection of Environment 31 2013-07-01 2013-07-01 false Organic Pesticide Active Ingredient... STANDARDS (CONTINUED) PESTICIDE CHEMICALS Pt. 455, Table 3 Table 3 to Part 455—Organic Pesticide Active...) Pesticide kg/kkg (lb/1,000 lb) pounds of pollutant per 1000 lbs product Daily maximum shall not exceed...
Code of Federal Regulations, 2014 CFR
2014-07-01
... 40 Protection of Environment 30 2014-07-01 2014-07-01 false Organic Pesticide Active Ingredient... STANDARDS (CONTINUED) PESTICIDE CHEMICALS Pt. 455, Table 3 Table 3 to Part 455—Organic Pesticide Active...) Pesticide kg/kkg (lb/1,000 lb) pounds of pollutant per 1000 lbs product Daily maximum shall not exceed...
Activity of two strobilurin fungicides against three species of decay fungi in agar plate tests
Juliet D. Tang; Tina Ciaramitaro; Maria Tomaso-Peterson; Susan V. Diehl
2017-01-01
The objective of this study was to examine the toxicity of strobilurin fungicides against wood decay fungi in order to assess their potential to act as a co-biocide for copper-based wood protection. Two strobilurin fungicides, Heritage (50% azoxystrobin active ingredient) and Insignia (20% pyraclostrobin active ingredients), and copper sulfate pentahydrate were tested...
Skin-Applied Repellent Ingredients
Active ingredients in EPA-registered insect repellents include catnip oil, oil of citronella, DEET, IR 3535, picaridin, oil of lemon eucalyptus, and 2-undecanone. Find fact sheets and pesticide regulatory information.
Types of Pesticide Ingredients
Pesticide active ingredients are described by the types of pests they control or how they work. For example, algicides kill algae, biopesticides are derived from natural materials, and insecticides kill insects.
Liu, Ze; Xie, Hua-Lin; Chen, Lin; Huang, Jian-Hua
2018-05-02
Background: Pu-erh tea is a unique microbially fermented tea, which distinctive chemical constituents and activities are worthy of systematic study. Near infrared spectroscopy (NIR) coupled with suitable chemometrics approaches can rapidly and accurately quantitatively analyze multiple compounds in samples. Methods: In this study, an improved weighted partial least squares (PLS) algorithm combined with near infrared spectroscopy (NIR) was used to construct a fast calibration model for determining four main components, i.e., tea polyphenols, tea polysaccharide, total flavonoids, theanine content, and further determine the total antioxidant capacity of pu-erh tea. Results: The final correlation coefficients R square for tea polyphenols, tea polysaccharide, total flavonoids content, theanine content, and total antioxidant capacity were 0.8288, 0.8403, 0.8415, 0.8537 and 0.8682, respectively. Conclusions : The current study provided a comprehensive study of four main ingredients and activity of pu-erh tea, and demonstrated that NIR spectroscopy technology coupled with multivariate calibration analysis could be successfully applied to pu-erh tea quality assessment.
Saïdi, Fadila; Taulelle, Francis; Martineau, Charlotte
2016-08-01
In this contribution, we present an analysis of the main parameters influencing the efficiency of the (1)H → (13)C multiple-contact cross-polarization nuclear magnetic resonance (NMR) experiment in the context of solid pharmaceutical materials. Using the optimum experimental conditions, quantitative (13)C NMR spectra are then obtained for porous metal-organic frameworks (potential drug carriers) and for components present in drug formulations (active principle ingredient and excipients, amorphous or crystalline). Finally, we show that mixtures of components can also be quantified with this method and, hence, that it represents an ideal tool for quantification of pharmaceutical formulations by (13)C cross-polarization under magic-angle spinning NMR in the industry as it is robust and easy to set up, much faster than direct (13)C polarization and is efficient for samples at natural abundance. Copyright © 2016 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.
Huang, Jihan; Cheung, Fan; Tan, Hor-Yue; Hong, Ming; Wang, Ning; Yang, Juan; Feng, Yibin; Zheng, Qingshan
2017-01-01
Yinchenhao decoction (YCHD) is a traditional Chinese medicine formulation, which has been widely used for the treatment of jaundice for 2,000 years. Currently, YCHD is used to treat various liver disorders and metabolic diseases, however its chemical/pharmacologic profiles remain to be elucidated. The present study identified the active compounds and significant pathways of YCHD based on network pharmacology. All of the chemical ingredients of YCHD were retrieved from the Traditional Chinese Medicine Systems Pharmacology database. Absorption, distribution, metabolism and excretion screening with oral bioavailability (OB) screening, drug-likeness (DL) and intestinal epithelial permeability (Caco-2) evaluation were applied to discover the bioactive compounds in YCHD. Following this, target prediction, pathway identification and network construction were employed to clarify the mechanism of action of YCHD. Following OB screening, and evaluation of DL and Caco-2, 34 compounds in YCHD were identified as potential active ingredients, of which 30 compounds were associated with 217 protein targets. A total of 31 significant pathways were obtained by performing enrichment analyses of 217 proteins using the JEPETTO 3.x plugin, and 16 classes of gene-associated diseases were revealed by performing enrichment analyses using Database for Annotation, Visualization and Integrated Discovery v6.7. The present study identified potential active compounds and significant pathways in YCHD. In addition, the mechanism of action of YCHD in the treatment of various diseases through multiple pathways was clarified. PMID:28791364
[New drugs for small animals in 2017].
Emmerich, Ilka Ute
2018-04-01
In 2017 the active pharmaceutical ingredient Lokivetmab (Cytopoint®), a caninized anti-canine Interleukin 31 monoclonal antibody, was released on the German market for small animals. One substance was authorized for an additional species. Sarolaner, an ectoparasiticide of the isoxazoline group, is now authorized for use in combination with Selamectin (Stronghold® Plus) additionally for cats. The testosterone derivate Nandrolone (Nandrosol®) and the combination of the benzodiazepine Zolazepam with the "dissociative anesthetic" Tiletamine (Zoletil®) were once again authorized. Furthermore, two veterinary drugs with a new combination of active ingredients, one drug with a new active ingredient and two veterinary drugs with a new pharmaceutical form have been launched on the market for small animals. Schattauer GmbH.
[New drugs for horses and production animals in 2017].
Emmerich, Ilka Ute
2018-04-01
In 2017, no new active pharmaceutical ingredients were released on the German market for horses or food-producing animals. Four established veterinary active pharmaceutical ingredients became available for additional species: the ectoparasitic Fluralaner (Exzolt®) of the isoxazoline group was additionally authorized for chickens, the macrolide antibiotics Gamithromycin (Zactran®) and Tulathromycin (Draxxin®) for sheep and the nonsteroidal anti-inflammatory drug Tolfenamic Acid (Tolfedol®) from the fenamate group for cattle and pigs. Additionally, one drug with a new combination of active ingredients, one drug with a new pharmaceutical form and one drug with a new mode of administration have been launched on the market for horses and food-producing animals. Schattauer GmbH.
Code of Federal Regulations, 2014 CFR
2014-04-01
... administration. It contains, in addition to the active ingredient(s), mixtures of acids (citric acid, tartaric acid) and sodium bicarbonate, which release carbon dioxide when dissolved in water. [51 FR 35339, Oct...
Code of Federal Regulations, 2011 CFR
2011-04-01
... administration. It contains, in addition to the active ingredient(s), mixtures of acids (citric acid, tartaric acid) and sodium bicarbonate, which release carbon dioxide when dissolved in water. [51 FR 35339, Oct...
Code of Federal Regulations, 2012 CFR
2012-04-01
... administration. It contains, in addition to the active ingredient(s), mixtures of acids (citric acid, tartaric acid) and sodium bicarbonate, which release carbon dioxide when dissolved in water. [51 FR 35339, Oct...
Code of Federal Regulations, 2013 CFR
2013-04-01
... administration. It contains, in addition to the active ingredient(s), mixtures of acids (citric acid, tartaric acid) and sodium bicarbonate, which release carbon dioxide when dissolved in water. [51 FR 35339, Oct...
Difficulties in avoiding exposure to allergens in cosmetics.
Noiesen, Eline; Munk, Martin D; Larsen, Kristian; Johansen, Jeanne Duus; Agner, Tove
2007-08-01
The aim of the study is to describe the ability of patients with allergic contact dermatitis to avoid exposure to allergens in cosmetics. The study is a questionnaire survey among 382 patients with contact allergy to preservatives and fragrances, included from 3 dermatological clinics. The questionnaire included questions about the level of difficulty in reading labels of ingredients on cosmetics and about patients' strategies to avoid substances they were allergic to. It also included questions about eczema severity as well as about educational level. 46% of the patients found it difficult or extremely difficult to read the ingredient labelling of cosmetics, and this finding was significantly related to low educational level. Patients allergic to formaldehyde and methyldibromo glutaronitrile experienced the worst difficulties, while patients with fragrance allergy found ingredient label reading easier than patients with preservative allergy. Reading of ingredient labels is a major problem for patients with contact allergy to allergens in consumer products. It is a general problem for all patients and not restricted to a small group with multiple allergies.
Defarge, Nicolas; Takács, Eszter; Lozano, Verónica Laura; Mesnage, Robin; Spiroux de Vendômois, Joël; Séralini, Gilles-Eric; Székács, András
2016-01-01
Pesticide formulations contain declared active ingredients and co-formulants presented as inert and confidential compounds. We tested the endocrine disruption of co-formulants in six glyphosate-based herbicides (GBH), the most used pesticides worldwide. All co-formulants and formulations were comparably cytotoxic well below the agricultural dilution of 1% (18–2000 times for co-formulants, 8–141 times for formulations), and not the declared active ingredient glyphosate (G) alone. The endocrine-disrupting effects of all these compounds were measured on aromatase activity, a key enzyme in the balance of sex hormones, below the toxicity threshold. Aromatase activity was decreased both by the co-formulants alone (polyethoxylated tallow amine—POEA and alkyl polyglucoside—APG) and by the formulations, from concentrations 800 times lower than the agricultural dilutions; while G exerted an effect only at 1/3 of the agricultural dilution. It was demonstrated for the first time that endocrine disruption by GBH could not only be due to the declared active ingredient but also to co-formulants. These results could explain numerous in vivo results with GBHs not seen with G alone; moreover, they challenge the relevance of the acceptable daily intake (ADI) value for GBHs exposures, currently calculated from toxicity tests of the declared active ingredient alone. PMID:26927151
Federal Register 2010, 2011, 2012, 2013, 2014
2010-02-22
... in OTC drug monographs based on time and extent applications (TEAs). We are currently evaluating the... effectiveness of 13 active ingredients found eligible for possible addition to an OTC drug monograph via the TEA... ingredients found eligible for inclusion in an OTC drug monograph under the TEA process on the basis of...
Desmarchelier, Cristian
2010-06-01
Despite the advent of biotechnology and modern methods of combinatorial chemistry and rational drug design, nature still plays a surprisingly important role as a source of new pharmaceutical compounds. These are marketed either as herbal drugs or as single active ingredients. South American tropical ecosystems (or the Neotropics) encompass one-third of the botanical biodiversity of the planet. For centuries, indigenous peoples have been using plants for healing purposes, and scientists are making considerable efforts in order to validate these uses from a pharmacological/phytochemical point of view. However, and despite the unique plant diversity in the region, very few natural pharmaceutical ingredients from this part of the world have reached the markets in industrialized countries. The present review addresses the importance of single active ingredients and herbal drugs from South American flora as natural ingredients for pharmaceuticals; it highlights the most relevant cases in terms of species of interest; and discusses the key entry barriers for these products in industrialized countries. It explores the reasons why, in spite of the region's competitive advantages, South American biodiversity has been a poor source of natural ingredients for the pharmaceutical industry. (c) 2010 John Wiley & Sons, Ltd.
Code of Federal Regulations, 2013 CFR
2013-07-01
... 40 Protection of Environment 31 2013-07-01 2013-07-01 false Organic Pesticide Active Ingredient Effluent Limitations Best Available Technology Economically Achievable (BAT) and Pretreatment Standards for... Economically Achievable (BAT) and Pretreatment Standards for Existing Sources (PSES) Pesticide kg/kkg (lb/1,000...
21 CFR 341.85 - Labeling of permitted combinations of active ingredients.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Labeling of permitted combinations of active ingredients. 341.85 Section 341.85 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE COLD, COUGH, ALLERGY, BRONCHODILATOR, AND ANTIASTHMATIC DRUG...
EPA Pesticide Chemical Search allows a user to easily find the pesticide chemical or active ingredient that they are interested in by using an array of simple to advanced search options. Chemical Search provides a single point of reference for easy access to information previously published in a variety of locations, including various EPA web pages and Regulations.gov.
Federal Register 2010, 2011, 2012, 2013, 2014
2013-03-06
... products containing currently registered active ingredients pursuant to the provisions of section 3(c) of... registered active ingredients. Pursuant to the provisions of FIFRA section 3(c)(4), EPA is hereby providing..., crop subgroup 3-07B including Chinese chive (fresh leaves), chive (fresh leaves), elegans hosta...
ERIC Educational Resources Information Center
White, Andrew S.; Howell Smith, Michelle; Kunz, Gina M.; Nugent, Gwen C.
2015-01-01
Although researchers have explored the impact of instructional coaching and named possible elements believed essential to effective coaching, there has yet to emerge from the literature a coherent model of those essential elements ("active ingredients"). This qualitative study sought to identify those elements through a systematic…
Leaching of biocides used in façade coatings under laboratory test conditions.
Schoknecht, Ute; Gruycheva, Jana; Mathies, Helena; Bergmann, Hannelore; Burkhardt, Michael
2009-12-15
The European Biocidal Products Directive 98/8/EC requires a risk assessment concerning possible effects of active ingredients on the environment. Biocides can be leached from treated materials exposed to outdoor use. These emissions have to be estimated and evaluated during the authorization procedure. Different immersion and irrigation tests were performed to investigate leaching of biocides from façade coatings. Several marketed formulations of textured coatings and paints spiked with a mixture of commonly used active ingredients (OIT, DCOIT, IPBC, carbendazim, isoproturon, diuron, terbutryn, and Irgarol 1051) were investigated. The emission process can be described by time-dependent functions that depend on the test conditions. The results of all test procedures confirm that leachability is related to water solubility and n-octanol-water partition coefficient of the active ingredients and that leaching of biocides from façade coatings is mainly a diffusion controlled process. Other factors like the composition of the product, availability and transport of water, concentration of active ingredients in the coatings, as well as UV-exposure of the coatings influence biocide emissions.
Horkovics-Kovats, Stefan
2014-02-01
Dissolution profile of a finished dosage form (FDF) contains hidden information regarding the disintegration of the form and the particle properties of the active pharmaceutical ingredient. Here, an extraction of this information from the dissolution profile without limitation to sink conditions is provided. In the article, mathematical relationships between the continuously measured dissolution profile of an FDF containing uniform or heterogeneous particles and its disintegration rate are developed. Further, the determinability of the disintegration kinetics and particle properties released from an FDF using the derived recurrent procedure was analyzed. On the basis of the theoretical data sets, it was demonstrated that the introduced analysis of dissolution profiles correctly identifies the disintegration rate of FDF containing multiple particle types. Furthermore, for known disintegration rates, the intrinsic lifetime of particles (time needed for total particle dissolution in infinite volume) released from the FDF and their relative amount can be determined. The extractable information from FDF dissolution time profiles can be utilized in designing of the formulation process, resulting in improved understanding of FDF properties, contributing thus to the implementation of quality by design in the FDF development. © 2013 Wiley Periodicals, Inc. and the American Pharmacists Association.
Bosch, Dolors; Rodríguez, Marcela A; Avilla, Jesús
2018-04-01
Widespread resistance of Cydia pomonella to organophosphates was demonstrated in populations from the Spanish Ebro Valley area which showed high levels of enzymatic detoxification. To determine the efficacy of new insecticides, neonate larval bioassays were carried out on 20 field codling moth populations collected from three different Spanish apple production areas. Synergist bioassays were performed to determine the enzymatic mechanisms involved. The least active ingredients were methoxyfenozide, with 100% of the populations showing significantly lower mortality than the susceptible strain, and lambda-cyhalothrin, with very high resistance ratios (872.0 for the most resistant field population). Approximately 50% of the populations were resistant or tolerant to thiacloprid. By contrast, tebufenozide was very effective in all the field populations, as was chlorpyrifos-ethyl despite its widespread use during the last few years. Indoxacarb, spinosad and chlorantraniliprole also provided high efficacy, as did emamectin and spinetoram, which are not yet registered in Spain. The resistant Spanish codling moth populations can be controlled using new reduced-risk insecticides. The use of synergists showed the importance of the concentration applied and the difficulty of interpreting results in field populations that show multiple resistance to different active ingredients. © 2017 Society of Chemical Industry. © 2017 Society of Chemical Industry.
Hayashi, Yoshihiro; Oishi, Takuya; Shirotori, Kaede; Marumo, Yuki; Kosugi, Atsushi; Kumada, Shungo; Hirai, Daijiro; Takayama, Kozo; Onuki, Yoshinori
2018-07-01
The aim of this study was to explore the potential of boosted tree (BT) to develop a correlation model between active pharmaceutical ingredient (API) characteristics and a tensile strength (TS) of tablets as critical quality attributes. First, we evaluated 81 kinds of API characteristics, such as particle size distribution, bulk density, tapped density, Hausner ratio, moisture content, elastic recovery, molecular weight, and partition coefficient. Next, we prepared tablets containing 50% API, 49% microcrystalline cellulose, and 1% magnesium stearate using direct compression at 6, 8, and 10 kN, and measured TS. Then, we applied BT to our dataset to develop a correlation model. Finally, the constructed BT model was validated using k-fold cross-validation. Results showed that the BT model achieved high-performance statistics, whereas multiple regression analysis resulted in poor estimations. Sensitivity analysis of the BT model revealed that diameter of powder particles at the 10th percentile of the cumulative percentage size distribution was the most crucial factor for TS. In addition, the influences of moisture content, partition coefficients, and modal diameter were appreciably meaningful factors. This study demonstrates that BT model could provide comprehensive understanding of the latent structure underlying APIs and TS of tablets.
Richards, R M; Xing, J Z; Weir, L F
1996-04-01
The purpose of this investigation was to determine the influence on the antimicrobial activity of cetylpyridinium chloride of the various components of the formulation of each of six candy based lozenges. In vivo activity was investigated using six volunteers by determining the reduction in colony forming units recoverable from the oropharynx after sucking each lozenge separately on different days. In vitro determinations investigated the relative activity of aqueous solutions of the lozenges, the effect on activity of additional active ingredients, pH and lozenge base ingredients against separate inocula of each of the test organisms Staphylococcus aureus, Streptococcus pyogenes and Candida albicans. Both in vivo and in vitro results showed that the pH of the dissolved lozenge solution was the single most influential readily adjustable formulation parameter which significantly influenced the activity of cetylpyridinium chloride activity in candy based lozenges. Lozenges containing cetylpyridinium chloride as the active ingredient should be formulated at a pH greater than 5.5.
Hosseini, Azar; Hosseinzadeh, Hossein
2018-03-01
Curcuma longa is a rhizomatous perennial herb that belongs to the family Zingiberaceae, native to South Asia and is commonly known as turmeric. It is used as herbal remedy due to the prevalent belief that the plant has medical properties. C. longa possesses different effects such as antioxidant, anti-tumor, antimicrobial, anti-inflammatory, wound healing, and gastroprotective activities. The recent studies have shown that C. longa and curcumin, its important active ingredient, have protective effects against toxic agents. In this review article, we collected in vitro and animal studies which are related to protective effects of turmeric and its active ingredient against natural and chemical toxic agents. Copyright © 2018 Elsevier Masson SAS. All rights reserved.
Wang, Le; Tan, Nana; Hu, Jiayao; Wang, Huan; Duan, Dongzhu; Ma, Lin; Xiao, Jian; Wang, Xiaoling
2017-12-28
Osmanthus fragrans has been used as folk medicine for thousands of years. The extracts of Osmanthus fragrans flowers were reported to have various bioactivities including free radical scavenging, anti-inflammation, neuroprotection and antitumor effects. However, there is still lack of knowledge about its essential oil. In this work, we analyzed the chemical composition of the essential oil from Osmanthus fragrans var. thunbergii by GC-MS. A complex network approach was applied to investigate the interrelationships between the ingredients, target proteins, and related pathways for the essential oil. Statistical characteristics of the networks were further studied to explore the main active ingredients and potential bioactivities of O. fragrans var. thunbergii essential oil. A total of 44 ingredients were selected from the chemical composition of O. fragrans var. thunbergii essential oil, and that 191 potential target proteins together with 70 pathways were collected for these compounds. An ingredient-target-pathway network was constructed based on these data and showed scale-free property as well as power-law degree distribution. Eugenol and geraniol were screened as main active ingredients with much higher degree values. Potential neuroprotective and anti-tumor effect of the essential oil were also found. A core subnetwork was extracted from the ingredient-target-pathway network, and indicated that eugenol and geraniol contributed most to the neuroprotection of this essential oil. Furthermore, a pathway-based protein association network was built and exhibited small-world property. MAPK1 and MAPK3 were considered as key proteins with highest scores of centrality indices, which might play an important role in the anti-tumor effect of the essential oil. This work predicted the main active ingredients and bioactivities of O. fragrans var. thunbergii essential oil, which would benefit the development and utilization of Osmanthus fragrans flowers. The application of complex network theory was proved to be effective in bioactivities studies of essential oil. Moreover, it provides a novel strategy for exploring the molecular mechanisms of traditional medicines.
Elskus, Adria A.
2007-01-01
Blueberry pesticides have been detected consistently in some Down East Maine rivers, yet little is known about the sublethal effects of these pesticides on fish early life stages. The Maine blueberry industry is proposing to replace the insecticide ImidanTM (active ingredient phosmet) and the herbicide VelparTM (active ingredient hexazinone), two of the pesticides found in these rivers, with candidate alternatives SpinTor TM (active ingredient spinosad) and Callistso TM (active ingredient mesotrione). Our objective is to evaluate potential sublethal effects of these four formulations before the industry adopts the two candidate alternatives. We exposed zebrafish (Danio rerio) early life stages, from fertilization through larval swim-up, to a range of pesticide concentrations and evaluated their response relative to untreated controls. In this report we provide preliminary data on immune function as well as on parameters in addition to those originally proposed: development and performance fitness. We also provide information on our progress towards optimizing chemical protocols for analyzing the concentration of active ingredient in each of our formulation dosing solutions, another new parameter we added to those originally proposed. Preliminary results indicate that at environmentally realistic concentrations, these pesticides may have no significant effect on innate immunity, development rate or behavior (spontaneous swimming), however further replication is needed to confirm these initial findings. We have also observed some degree of developmental abnormalities in both pesticide-treated and control zebrafish embryos; however, additional replication is underway to determine if these groups differ significantly.
Xian, Yan-Fang; Lin, Zhi-Xiu; Mao, Qing-Qiu; Hu, Zhen; Zhao, Ming; Che, Chun-Tao; Ip, Siu-Po
2012-01-01
Uncaria rhynchophylla is a component herb of many Chinese herbal formulae for the treatment of neurodegenerative diseases. Previous study in our laboratory has demonstrated that an ethanol extract of Uncaria rhynchophylla ameliorated cognitive deficits in a mouse model of Alzheimer's disease induced by D-galactose. However, the active ingredients of Uncaria rhynchophylla responsible for the anti-Alzheimer's disease activity have not been identified. This study aims to identify the active ingredients of Uncaria rhynchophylla by a bioassay-guided fractionation approach and explore the acting mechanism of these active ingredients by using a well-established cellular model of Alzheimer's disease, beta-amyloid- (Aβ-) induced neurotoxicity in PC12 cells. The results showed that six alkaloids, namely, corynoxine, corynoxine B, corynoxeine, isorhynchophylline, isocorynoxeine, and rhynchophylline were isolated from the extract of Uncaria rhynchophylla. Among them, rhynchophylline and isorhynchophylline significantly decreased Aβ-induced cell death, intracellular calcium overloading, and tau protein hyperphosphorylation in PC12 cells. These results suggest that rhynchophylline and isorhynchophylline are the major active ingredients responsible for the protective action of Uncaria rhynchophylla against Aβ-induced neuronal toxicity, and their neuroprotective effect may be mediated, at least in part, by inhibiting intracellular calcium overloading and tau protein hyperphosphorylation. PMID:22778778
Xian, Yan-Fang; Lin, Zhi-Xiu; Mao, Qing-Qiu; Hu, Zhen; Zhao, Ming; Che, Chun-Tao; Ip, Siu-Po
2012-01-01
Uncaria rhynchophylla is a component herb of many Chinese herbal formulae for the treatment of neurodegenerative diseases. Previous study in our laboratory has demonstrated that an ethanol extract of Uncaria rhynchophylla ameliorated cognitive deficits in a mouse model of Alzheimer's disease induced by D-galactose. However, the active ingredients of Uncaria rhynchophylla responsible for the anti-Alzheimer's disease activity have not been identified. This study aims to identify the active ingredients of Uncaria rhynchophylla by a bioassay-guided fractionation approach and explore the acting mechanism of these active ingredients by using a well-established cellular model of Alzheimer's disease, beta-amyloid- (Aβ-) induced neurotoxicity in PC12 cells. The results showed that six alkaloids, namely, corynoxine, corynoxine B, corynoxeine, isorhynchophylline, isocorynoxeine, and rhynchophylline were isolated from the extract of Uncaria rhynchophylla. Among them, rhynchophylline and isorhynchophylline significantly decreased Aβ-induced cell death, intracellular calcium overloading, and tau protein hyperphosphorylation in PC12 cells. These results suggest that rhynchophylline and isorhynchophylline are the major active ingredients responsible for the protective action of Uncaria rhynchophylla against Aβ-induced neuronal toxicity, and their neuroprotective effect may be mediated, at least in part, by inhibiting intracellular calcium overloading and tau protein hyperphosphorylation.
Immunomodulatory and therapeutic properties of the Nigella sativa L. seed.
Salem, Mohamed Labib
2005-12-01
A larger number of medicinal plants and their purified constituents have been shown beneficial therapeutic potentials. Seeds of Nigella sativa, a dicotyledon of the Ranunculaceae family, have been employed for thousands of years as a spice and food preservative. The oil and seed constituents, in particular thymoquinine (TQ), have shown potential medicinal properties in traditional medicine. In view of the recent literature, this article lists and discusses different immunomodulatory and immunotherapeutic potentials for the crude oil of N. sativa seeds and its active ingredients. The published findings provide clear evidence that both the oil and its active ingredients, in particular TQ, possess reproducible anti-oxidant effects through enhancing the oxidant scavenger system, which as a consequence lead to antitoxic effects induced by several insults. The oil and TQ have shown also potent anti-inflammatory effects on several inflammation-based models including experimental encephalomyelitis, colitis, peritonitis, oedama, and arthritis through suppression of the inflammatory mediators prostaglandins and leukotriens. The oil and certain active ingredients showed beneficial immunomodulatory properties, augmenting the T cell- and natural killer cell-mediated immune responses. Most importantly, both the oil and its active ingredients expressed anti-microbial and anti-tumor properties toward different microbes and cancers. Coupling these beneficial effects with its use in folk medicine, N. sativa seed is a promising source for active ingredients that would be with potential therapeutic modalities in different clinical settings. The efficacy of the active ingredients, however, should be measured by the nature of the disease. Given their potent immunomodulatory effects, further studies are urgently required to explore bystander effects of TQ on the professional antigen presenting cells, including macrophages and dendritic cells, as well as its modulatory effects upon Th1- and Th2-mediated inflammatory immune diseases. Ultimately, results emerging from such studies will substantially improve the immunotherapeutic application of TQ in clinical settings.
DOE Office of Scientific and Technical Information (OSTI.GOV)
Chian, E.S.K.; Wu, T.P.; Rowland, R.W.
1980-10-01
Ultrafiltration (UF) and Reverse Osmosis (RO) treatment of Aqueous Film Forming Foam (AFFF) solutions was investigated to determine the feasibility of employing membrane processes to separate and recover AFFF active ingredients for reuse. Studies were performed on both 6% AFFF in tap-water solutions and on actual wastewaters spiked with 3% or 6% AFFF. The AFFF materials used in this study consisted of Ansul, 3M FC-206, and 3M FC-780. Membrane employed for these studies included Abcor HFD, HFF, HFJ, and HFK tubular ultrafiltration (UF) membranes and a DuPont B-10 reverse osmosis (RO) module. Parameters monitored to represent AFFF ingredients were TOC,more » dissolved solids, surfactants, and % glycol. An attempt was also made to determine fluorocarbons as fluoride. Membrane fluxes were also determined. Results of this study demonstrate the feasibility of employing UF-RO processes to separate and recover the AFFF active ingredients for reuse. Approximately 75% recovery of the AFFF active ingredients as represented by the foam test was attained. An economic analysis of the membrane treatment processes indicates that it is extremely favorable in recovering the AFFF wastewater for reuse. Pilot-scale studies are, however, necessary to fully establish the process feasibilities and economics of the AFFF recovery system.« less
[Advance in studies on Aconitum traditional Chinese medicines in toxicokinetics and metabonomics].
Ma, Tian-Yu; Yu, Teng-Fei; Li, Shu-Min; Li, Gang
2014-06-01
Aconitum, as a kind of common traditional Chinese medicine, contains multiple biological active substances, with a very high medicinal value but high toxicity. Its major toxic ingredients are aconitine, mesaconitine and hypaconitine, which are also efficient ingredients. Therefore, the safety of its clinical application has aroused wide attention. With the constant deepening of drug development studies, people want to learn about its toxic mechanism and the regularity of its emergence and development of its toxicology, so as to make a scientific and rational assessment for its safety. Therefore, toxicokinetics and metabonomics have gradually become important content in the new drug assessment. During the development of drug performance, it is crucial to establish a scientific, objective and standardized Aconitum safety evaluation system and correctly assess and utilize its toxicity. Having summarized studies on metabonomics and toxicokinetics of Aconitum drugs in recent years, authors proposed to strengthen the studies on Aconitum drug safety assessment and establish a scientific and standardized safety evaluation system as soon as possible, in order to make the national treasure more useful.
Extrusion-spheronization: process variables and characterization.
Sinha, V R; Agrawal, M K; Agarwal, A; Singh, G; Ghai, D
2009-01-01
Multiparticulate systems have undergone great development in the past decade fueled by the better understanding of their multiple roles as a suitable delivery system. With the passage of time, significant advances have been made in the process of pelletization due to the incorporation of specialized techniques for their development. Extrusion-spheronization seems to be the most promising process for the optimum delivery of many potent drugs having high systemic toxicity. It also offers immense pharmaceutical applicability due to the benefits of high loading capacity of active ingredient(s), narrow size distribution, and cost-effectiveness. On application of a specific coat, these systems can also aid in site-specific delivery, thereby enhancing the bioavailability of many drugs. The current review focuses on the process of extrusion-spheronization and the operational (extruder types, screen pressure, screw speed, temperature, moisture content, spheronization load, speed and time) and formulation (excipients and drugs) variables, which may affect the quality of the final pellets. Various methods for the evaluation of the quality of the pellets with regard to the size distribution, shape, friability, granule strength, density, porosity, flow properties, and surface texture are discussed.
Reverse translation of adverse event reports paves the way for de-risking preclinical off-targets.
Maciejewski, Mateusz; Lounkine, Eugen; Whitebread, Steven; Farmer, Pierre; DuMouchel, William; Shoichet, Brian K; Urban, Laszlo
2017-08-08
The Food and Drug Administration Adverse Event Reporting System (FAERS) remains the primary source for post-marketing pharmacovigilance. The system is largely un-curated, unstandardized, and lacks a method for linking drugs to the chemical structures of their active ingredients, increasing noise and artefactual trends. To address these problems, we mapped drugs to their ingredients and used natural language processing to classify and correlate drug events. Our analysis exposed key idiosyncrasies in FAERS, for example reports of thalidomide causing a deadly ADR when used against myeloma, a likely result of the disease itself; multiplications of the same report, unjustifiably increasing its importance; correlation of reported ADRs with public events, regulatory announcements, and with publications. Comparing the pharmacological, pharmacokinetic, and clinical ADR profiles of methylphenidate, aripiprazole, and risperidone, and of kinase drugs targeting the VEGF receptor, demonstrates how underlying molecular mechanisms can emerge from ADR co-analysis. The precautions and methods we describe may enable investigators to avoid confounding chemistry-based associations and reporting biases in FAERS, and illustrate how comparative analysis of ADRs can reveal underlying mechanisms.
21 CFR 700.35 - Cosmetics containing sunscreen ingredients.
Code of Federal Regulations, 2010 CFR
2010-04-01
.... Sunscreen active ingredients affect the structure or function of the body by absorbing, reflecting, or... premature skin aging, skin cancer, and other harmful effects due to the sun when used in conjunction with...
Seeram, Navindra P; Adams, Lynn S; Henning, Susanne M; Niu, Yantao; Zhang, Yanjun; Nair, Muraleedharan G; Heber, David
2005-06-01
Pomegranate (Punica granatum L.) fruits are widely consumed as juice (PJ). The potent antioxidant and anti-atherosclerotic activities of PJ are attributed to its polyphenols including punicalagin, the major fruit ellagitannin, and ellagic acid (EA). Punicalagin is the major antioxidant polyphenol ingredient in PJ. Punicalagin, EA, a standardized total pomegranate tannin (TPT) extract and PJ were evaluated for in vitro antiproliferative, apoptotic and antioxidant activities. Punicalagin, EA and TPT were evaluated for antiproliferative activity at 12.5-100 microg/ml on human oral (KB, CAL27), colon (HT-29, HCT116, SW480, SW620) and prostate (RWPE-1, 22Rv1) tumor cells. Punicalagin, EA and TPT were evaluated at 100 microg/ml concentrations for apoptotic effects and at 10 microg/ml concentrations for antioxidant properties. However, to evaluate the synergistic and/or additive contributions from other PJ phytochemicals, PJ was tested at concentrations normalized to deliver equivalent amounts of punicalagin (w/w). Apoptotic effects were evaluated against the HT-29 and HCT116 colon cancer cell lines. Antioxidant effects were evaluated using inhibition of lipid peroxidation and Trolox equivalent antioxidant capacity (TEAC) assays. Pomegranate juice showed greatest antiproliferative activity against all cell lines by inhibiting proliferation from 30% to 100%. At 100 microg/ml, PJ, EA, punicalagin and TPT induced apoptosis in HT-29 colon cells. However, in the HCT116 colon cells, EA, punicalagin and TPT but not PJ induced apoptosis. The trend in antioxidant activity was PJ>TPT>punicalagin>EA. The superior bioactivity of PJ compared to its purified polyphenols illustrated the multifactorial effects and chemical synergy of the action of multiple compounds compared to single purified active ingredients.
Near-Infrared Spectroscopy Assay of Key Quality-Indicative Ingredients of Tongkang Tablets.
Pan, Wenjie; Ma, Jinfang; Xiao, Xue; Huang, Zhengwei; Zhou, Huanbin; Ge, Fahuan; Pan, Xin
2017-04-01
The objective of this paper is to develop an easy and fast near-infrared spectroscopy (NIRS) assay for the four key quality-indicative active ingredients of Tongkang tablets by comparing the true content of the active ingredients measured by high performance liquid chromatography (HPLC) and the NIRS data. The HPLC values for the active ingredients content of Cimicifuga glycoside, calycosin glucoside, 5-O-methylvisamminol and hesperidin in Tongkang tablets were set as reference values. The NIRS raw spectra of Tongkang tablets were processed using first-order convolution method. The iterative optimization method was chosen to optimize the band for Cimicifuga glycoside and 5-O-methylvisamminol, and correlation coefficient method was used to determine the optimal band of calycosin glucoside and hesperidin. A near-infrared quantitative calibration model was established for each quality-indicative ingredient by partial least-squares method on the basis of the contents detected by HPLC and the obtained NIRS spectra. The correlation coefficient R 2 values of the four models of Cimicifuga glycoside, calycosin glucoside, 5-O-methylvisamminol and hesperidin were 0.9025, 0.8582, 0.9250, and 0.9325, respectively. It was demonstrated that the accuracy of the validation values was approximately 90% by comparison of the predicted results from NIRS models and the HPLC true values, which suggested that NIRS assay was successfully established and validated. It was expected that the quantitative analysis models of the four indicative ingredients could be used to rapidly perform quality control in industrial production of Tongkang tablets.
ERIC Educational Resources Information Center
Florida State Univ., Tallahassee. Center for Studies in Vocational Education.
This document consists of a learning activity packet (LAP) for the student and an instructor's guide for the teacher. The LAP is intended to acquaint occupational home economics students with yeast breads and their ingredients. Illustrated information sheets and learning activities are provided in these areas: yeast breads and their ingredients,…
Sandalwood Album Oil as a Botanical Therapeutic in Dermatology.
Moy, Ronald L; Levenson, Corey
2017-10-01
Many skin conditions and diseases are characterized by inflammation, infection, and hyperplasia. Safe and effective topical treatment options that can be used long-term are needed. Traditional botanical medicines, which are often complex mixtures that exert their biological activities via multiple mechanisms of action, are being studied as potential new active ingredients in dermatology. Sandalwood album oil (SAO), also known as East Indian sandalwood oil (EISO), is an essential oil distilled from the Santalum album tree and has demonstrated biological activity as an anti-inflammatory, anti-microbial, and anti-proliferative agent. Sandalwood album oil has also shown promise in clinical trials for treatment of acne, psoriasis, eczema, common warts, and molluscum contagiosum. The favorable safety profile, ease of topical use, and recent availability of pharmaceutical-grade sandalwood album oil support its broader use as the basis of novel therapies in dermatology.
Code of Federal Regulations, 2012 CFR
2012-04-01
... offered over-the-counter (OTC) for external use as hair growers or for hair loss prevention. 310.527... products containing active ingredients offered over-the-counter (OTC) for external use as hair growers or for hair loss prevention. (a) Amino acids, aminobenzoic acid, ascorbic acid, benzoic acid, biotin and...
Code of Federal Regulations, 2014 CFR
2014-04-01
... offered over-the-counter (OTC) for external use as hair growers or for hair loss prevention. 310.527... products containing active ingredients offered over-the-counter (OTC) for external use as hair growers or for hair loss prevention. (a) Amino acids, aminobenzoic acid, ascorbic acid, benzoic acid, biotin and...
Code of Federal Regulations, 2013 CFR
2013-04-01
... offered over-the-counter (OTC) for external use as hair growers or for hair loss prevention. 310.527... products containing active ingredients offered over-the-counter (OTC) for external use as hair growers or for hair loss prevention. (a) Amino acids, aminobenzoic acid, ascorbic acid, benzoic acid, biotin and...
Code of Federal Regulations, 2014 CFR
2014-07-01
... (CONTINUED) EFFLUENT GUIDELINES AND STANDARDS (CONTINUED) PESTICIDE CHEMICALS Organic Pesticide Chemicals....8000 pH * * * Within the range 6.0 to 9.0 ** Metric units: Kilogram pollutant/1,000 kg of total organic active ingredients. English units: Pound pollutant/1,000 lb of total organic active ingredients [58 FR...
Code of Federal Regulations, 2013 CFR
2013-07-01
... (CONTINUED) EFFLUENT GUIDELINES AND STANDARDS (CONTINUED) PESTICIDE CHEMICALS Organic Pesticide Chemicals....8000 pH * * * Within the range 6.0 to 9.0 ** Metric units: Kilogram pollutant/1,000 kg of total organic active ingredients. English units: Pound pollutant/1,000 lb of total organic active ingredients [58 FR...
Code of Federal Regulations, 2012 CFR
2012-07-01
... (CONTINUED) EFFLUENT GUIDELINES AND STANDARDS (CONTINUED) PESTICIDE CHEMICALS Organic Pesticide Chemicals....8000 pH * * * Within the range 6.0 to 9.0 ** Metric units: Kilogram pollutant/1,000 kg of total organic active ingredients. English units: Pound pollutant/1,000 lb of total organic active ingredients [58 FR...
Code of Federal Regulations, 2011 CFR
2011-07-01
... (CONTINUED) EFFLUENT GUIDELINES AND STANDARDS PESTICIDE CHEMICALS Organic Pesticide Chemicals Manufacturing....8000 pH * * * Within the range 6.0 to 9.0 ** Metric units: Kilogram pollutant/1,000 kg of total organic active ingredients. English units: Pound pollutant/1,000 lb of total organic active ingredients [58 FR...
Code of Federal Regulations, 2010 CFR
2010-07-01
... (CONTINUED) EFFLUENT GUIDELINES AND STANDARDS PESTICIDE CHEMICALS Organic Pesticide Chemicals Manufacturing....8000 pH * * * Within the range 6.0 to 9.0 ** Metric units: Kilogram pollutant/1,000 kg of total organic active ingredients. English units: Pound pollutant/1,000 lb of total organic active ingredients [58 FR...
USDA-ARS?s Scientific Manuscript database
We tested the efficacy of attractive toxic sugar bait (ATSB) with garlic oil microencapsulated in beta-cyclodextrin as active ingredient against Aedes albopictus in suburban Haifa, Israel. Two three-acre gardens with high numbers of Ae. albopictus were chosen for perimeter spray treatment with ATSB ...