The US Food and Drug Administration (FDA) on Wednesday issued a revised final guidance to assist manufacturers in detecting and controlling nitrosamine impurities in pharmaceutical products.
The guidance revises a previous version issued in February 2021 and includes some major changes. These changes include the addition of a new section on nitrosamine drug substance-related impurities (NDSRIs), as these novel nitrosamines were not addressed in the earlier guidance, as well as expanded information on FDA’s August 2023 guidance establishing acceptable intake limits for NDSRIs. (RELATED: FDA sets acceptable intake limits for nitrosamines in drugs, Regulatory Focus 7 August 2023)…
