Control Strategies And Method Development For Nitrosamines In APIs And Drug Products

This webinar will provide a comprehensive overview of method development strategies to control nitrosamines in drug substances and drug products, with a particular emphasis on platform approaches using LC-MS-MS, high-resolution LC-MS, and GC-MS. Attendees will gain insight into applying these analytical methods to complex drug substances and products, ensuring effective detection and control of nitrosamines. The session will include case studies highlighting method development and validation for nitrosamines of concern and strategies for managing drug-derived nitrosamines to achieve compliance by the August 2025 deadline.

Key Learning Objectives:

• Explore the regulatory landscape for nitrosamines and NDSRIs
• Learn how to select optimal analytical methods for nitrosamine assessment
• Understand various method development and validation strategies