Due to the potential carcinogenicity at low concentration, Nitrosamine Drug Substance-Related impurities (NDSRIs) are considered as a cohort of concern. Secondary amines present in the API and impurities can easily react with nitrite from the excipients. Risk assessment and the limit of intake have recently been updated and published in July-August 2023 by the European Medicines Agency (EMA), Health Canada (HC) and the Food and Drug Administration (FDA).
Our esteemed panel of experts will navigate through the regulatory frameworks established by the EMA and FDA, offering insights into risk assessment strategies, enhanced Ames test and cutting-edge analytical techniques crucial for Nitrosamine detection as well as OECD 471 adaptation, and detection strategies using LC-MS/MS and GC-MS.
