Review of Global Regulations, Analytical Approaches, and Risk Management for Nitrosamine Impurities in Pharmaceuticals

In this whitepaper you will learn:

• Regulatory Requirements: About the recent regulatory requirements from agencies like the FDA and EMEA concerning the assessment, confirmatory testing, and control of N-nitrosamines in pharmaceuticals, drug delivery systems, and biomedical devices.
• Potency of N-Nitroso Compounds: The classification of N-nitroso compounds as highly potent mutagenic carcinogens and their inclusion in the “Cohort of Concern” in ICH M7, emphasizing the need for highly-sensitive analytical methods to detect these impurities.
• Risk Assessment Deadlines: The risk assessment and confirmatory testing deadlines set by regulatory agencies for nitrosamines in all commercial products, underscoring the urgency and importance of compliance in the pharmaceutical industry.