Abstract:
Pharmaceutical impurities affect the quality of drugs, and their research is essential in drug development, production and sale. Recently, there have been tremendous advancements in instrumental techniques that allow rapid development of technologies and analytical methods in the research of pharmaceutical impurities. This review discusses the origins and analytical methods of pharmaceutical impurities including genotoxic impurities, and mainly describes the analytical techniques and strategies to assess the genotoxicity of impurities, providing technical references for the study of pharmaceutical impurities.