Did you know that 30% of approved active pharmaceutical ingredients (APIs) are susceptible to nitrosamine formation? Due to the potential carcinogenicity at low concentration, Nitrosamine Drug Substance-Related impurities (NDSRIs) are considered as a cohort of concern. In particular, 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).
Join us on March 4th during our webinar where SEQENS and GenEvolutioN will present how to cope with the new regulations for the development of Drug Substances and Drug Products.
During this webinar you will learn:
Intervenants: