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Nitrosamines: how to deal with the new guidance during Drug Product development?


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).

Watch this 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:

  • Insights from the new FDA / EMA / HC guidance update (July-August 2023) on Nitrosamine Drug Substance Related Impurities (NDSRIs)
  • How to perform a comprehensive risk assessment
  • What are the characteristics and the goals of enhanced Ames test for the evaluation of the mutagenic potential of NDSRIs
  • Strategies to control nitrosamine risk during drug development

Speakers :

  • Juliette Martin, PhD, Scientific Communication Manager, SEQENS
  • Gautier Decock, PhD, CRDO Managing Director, SEQENS
  • Isabelle Mouche, Managing Director, GenEvolutioN

Request the Webinar