Document Detail


Analytical approaches for the detection of epoxides and hydroperoxides in active pharmaceutical ingredients, drug products and herbals.
MedLine Citation:
PMID:  20031361     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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.
Authors:
D P Elder; D Snodin; A Teasdale
Publication Detail:
Type:  Journal Article; Review     Date:  2009-12-03
Journal Detail:
Title:  Journal of pharmaceutical and biomedical analysis     Volume:  51     ISSN:  1873-264X     ISO Abbreviation:  J Pharm Biomed Anal     Publication Date:  2010 Apr 
Date Detail:
Created Date:  2010-02-01     Completed Date:  2010-04-16     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  8309336     Medline TA:  J Pharm Biomed Anal     Country:  England    
Other Details:
Languages:  eng     Pagination:  1015-23     Citation Subset:  IM    
Copyright Information:
Copyright 2009 Elsevier B.V. All rights reserved.
Affiliation:
GlaxoSmithKline R&D, Park Road, Ware SG12 0DP, UK.
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MeSH Terms
Descriptor/Qualifier:
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:
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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