Classified assessment of genotoxic impurities (GTIs) and establishment of acceptable limits
Genotoxic impurities (GTIs) refer to a class of impurities in drugs that can directly or indirectly cause DNA damage and gene mutations, with carcinogenicity or potential carcinogenicity. To ensure the quality and safety of drugs, the European Medicines Agency (EMA) introduced regulations on the management of GTIs in 2002. Since then, organizations such as the US Food and Drug Administration (FDA) and the International Conference on Harmonisation (ICH) have also issued a series of guidelines on the definition, classification, limits, testing, and risk assessment procedures of GTIs. At present, GTIs have become one of the key indicators for drug approval and marketing, and also one of the top concerns for R&D personnel. By analyzing and summarizing the identification, classification, hazard assessment methods, limits, and other aspects of GTIs, this paper provides references for the control of GTIs.