| Analytical approaches for the detection of epoxides and hydroperoxides in active pharmaceutical ingredients, drug products and herbals. | |
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MedLine Citation:
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PMID: 20031361 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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This review summarizes the analytical approaches reported in the literature relating to epoxide and hydroperoxide impurities. It is intended that it should provide guidance for analysts faced by the need to control such impurities, particularly where this is due to concerns relating to their potential genotoxicity. An extensive search of the literature relating to this class of impurities revealed a large number of references relating to analysis of epoxides/hydroperoxides associated with herbal remedies. Given the general applicability of the analytical methodology and due to the widespread use of herbal products the authors decided to include herbal medicines in this review. The review also reflects on the very different approaches taken in terms of the assessment/control of genotoxic impurities for such herbal remedies to that required for pharmaceutical products. |
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Authors:
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D P Elder; D Snodin; A Teasdale |
Publication Detail:
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Type: Journal Article; Review Date: 2009-12-03 |
Journal Detail:
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Title: Journal of pharmaceutical and biomedical analysis Volume: 51 ISSN: 1873-264X ISO Abbreviation: J Pharm Biomed Anal Publication Date: 2010 Apr |
Date Detail:
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Created Date: 2010-02-01 Completed Date: 2010-04-16 Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 8309336 Medline TA: J Pharm Biomed Anal Country: England |
Other Details:
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Languages: eng Pagination: 1015-23 Citation Subset: IM |
Copyright Information:
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Copyright 2009 Elsevier B.V. All rights reserved. |
Affiliation:
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GlaxoSmithKline R&D, Park Road, Ware SG12 0DP, UK. |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Chemistry Techniques, Analytical* Drug Contamination* Epoxy Compounds / adverse effects, analysis* Humans Hydrogen Peroxide / analysis Mutagens / adverse effects, analysis* Peroxides / adverse effects, analysis* Plant Preparations / chemistry* Reproducibility of Results Risk Assessment Technology, Pharmaceutical / methods* |
| Chemical | |
Reg. No./Substance:
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0/Epoxy Compounds; 0/Mutagens; 0/Peroxides; 0/Plant Preparations; 7722-84-1/Hydrogen Peroxide |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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