1. ICH M7 (R2) Assessment and control of DNA reactive (mutagenic) impurities in Pharmaceuticals to limit potential carcinogenic risk, 2023, Incorporated in M7 guidelines of International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH).
2. Acceptable intakes (AIs) for 11 small molecule N-nitrosamines (NAs);Bercu;Regul. Toxicol. Pharm.,2023
3. Practical and science-based strategy for establishing acceptable intakes for drug products N-Nitrosamine impurities;Dobo;Chem. Res. Toxicol.,2022
4. U.S. Department of Health and Human Services., Control of Nitrosamine impurities in human drugs (2021), Available at https://www.fda.gov/media/141720/download.
5. Committee for medicinal products for human use., Nitrosamine impurities in human medicinal products (2020), Available at https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/pharmacovigilance-post-authorisation/referral-procedures-human-medicines/nitrosamine-impurities.