Nitrosamines contamination – is it still an issue today?

Nitrosamines contamination – is it still an issue today?

Panel Discussion

Information

Almost six years after N-nitrosodimethylamine (NDMA) contamination was first identified, the toxic short alkyl chain N-nitrosamine issue appears on the way to resolution. In contrast, N-Nitrosamine drug substance-related impurities (NDSRIs) are still a burgeoning issue with many new NDSRIs being reported on a weekly basis. This session will:

  • Review the latest guidelines on nitrosamine risk evaluation and risk assessment
  • Explore analytical techniques for determination of nitrosamine impurities
  • Discuss the path to international regulatory harmonisation.

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