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2023 RAPS Article of The Year: Addressing the Risks of Nitrosamine Contamination in Pharmaceuticals

Date: October 19th, 2023 at 11 am EDT.

Nitrosamines in pharmaceuticals became a topic of special concern when their presence at unacceptable levels in common medicines hit the news in 2018. Drug substance and drug product manufacturers have since been required to conduct risk assessments and, when necessary, perform confirmation tests and recall products to address the risks of nitrosamine contamination and potential genotoxicity.

Over the past five years, developments in process chemistry, analytical technology, and regulatory guidances have shaped the state of play for nitrosamine impurities in drug manufacturing. In this webinar, we will explore the current scientific and regulatory landscape for nitrosamines, highlighting the current requirements for assessing, controlling, and monitoring their presence as contaminants in pharmaceuticals.

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Topics will include:

  • Background on nitrosamines, including factors that increase the risk of contamination in pharmaceuticals
  • Recent scientific developments that have enhanced the requirements for risk assessment, testing, and mitigation
  • Regulatory guidance on assessing the risk of—and identifying the root cause for—potential nitrosamine impurities
  • Reporting and notification requirements for nitrosamines in pharmaceuticals
  • Recent FDA guidance on nitrosamine drug substance-related impurities (NDSRIs) and implementation requirements


Dr. Olu Aloba, Vice PresidentCMC Services
Dr. Marianthi Karakatsani, Director CMC Development Strategy

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