Strategies for the identification, control and determination of genotoxic impurities in drug substances: A pharmaceutical industry perspective

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.