Glossary
What is Genotoxic Impurity?
An impurity that can damage DNA and potentially cause mutations or cancer, even at very low levels. In pharmaceuticals, such impurities are controlled far more tightly than ordinary impurities, often at parts-per-million levels relative to the API, following ICH M7. Typical structural alerts include alkyl halides, sulfonate esters, epoxides, aromatic amines and N-nitroso compounds.