Journal
JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS
Volume 55, Issue 4, Pages 662-667Publisher
ELSEVIER SCIENCE BV
DOI: 10.1016/j.jpba.2010.11.039
Keywords
Identification; Control; Genotoxic impurities; Drug substances; Pharmaceutical industry
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Regulations alarmed the control of genotoxic impurities in drug substances at lower level based on the threshold of toxicological concern and daily dose. This review explores the details of various regulations and guidances, toxicology assessment, identification of structural alerts, synthetic origins, different synthetic approaches for elimination or control, various analytical determination strategies and pharmaceutical industry concern towards genotoxic impurities. (C) 2010 Elsevier B.V. All rights reserved.
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