Many impurities in drugs can produce toxic and side effects, which is a crucial factor affecting the safety and effectiveness of drugs, especially genotoxic impurities that can cause serious harm to human health with minimal exposure. Therefore, to ensure API quality and preparations, Genotoxic impurities are a class of impurities that must be paid attention to in the drug synthesis process. Genotoxic impurities from chemical reagents, chemical synthesis, and reaction are involved in all aspects of the drug synthesis process and the subsequent stability and possible degradation of the drug, which is a complex process. For potential carcinogenic or mutagenic substances and impurities with warning structures, the Ames test can generally be used to test the mutagenic ability of impurities.https://www.medicilon.com/services/drug-safety-evaluation/