On Aug. 4, 2023, FDA released a guidance document, Recommended Acceptable Intake Limits for Nitrosamine Drug Substance-Related Impurities (NDSRIs). The guidance gives both applicants and manufacturers of drugs recommendations for estimating the mutagenic and carcinogenic potential of NDSRIs that could be in drug products and gives acceptable intake (AI) limits for NDSRIs.
NDSRIs are a subcategory of nitrosamine impurities that share structural similarity to the API in drug products; NDSRIs often lack the compound-specific mutagenicity and carcinogenicity data necessary for informed safety assessments.
