Navigating the Whirlwind Surrounding N-Nitrosamine Impurities in APIs and Drug Products

Date/Time: October 1-2, 2025   |   8:30am -12:30 pm EDT

Location: On-line

About the Workshop:

Bringing together scientists from industry, the FDA, the USP, and the IGBA, the workshop will focus on regulatory, scientific and technical challenges surrounding the presence of N-nitrosamine impurities in active pharmaceutical ingredients (APIs) and drug products. Participants will explore cutting-edge methods, regulatory updates, and research developments regarding N-nitrosamines.

The workshop consists of two half-day virtual sessions, each held in the morning (U.S. time), featuring four to five concise presentations by experts in the field (20–40 minutes each) followed by a panel discussion during which attendees can have their follow-up questions answered.

Session 1: October 1, 2025

Focus: Regulatory Landscape and Challenges

This session will address:

• FDA Perspective on N-Nitrosamine Impurities
• International Generic and Biosimilar Medicines Association (IGBA) Perspective on Nitrosamine Impurities, the Worldwide Challenges
• ICH M7 Risk Assessment and Control of N-Nitrosamine Impurities
• Over-the Counter (OTC) Drug Products and their Challenges with N-Nitrosamine Impurities
• Prescription Drug Products and their Challenges with N-Nitrosamine Impurities

Session 2: October 2, 2025

Focus: Chemistry, Toxicology and Bioequivalence Issues

This session will address:

• Analytical Challenges for Measurement of N-Nitrosamines in APIs and Drug Products
• How USP is Contributing to All-Things N-Nitrosamine
• Challenges with Toxicology of N-Nitrosamines
• Reformulation of Drug Products to Reduce N-Nitrosamine Impurities
• Excipient-Related Challenges of N-Nitrosamine Impurities
• Use of Physiologically Based Pharmacokinetic (PBPK) Modeling Approaches to Demonstrate Bioequivalence of Immediate-Release Re-formulated Products Containing BCS-IV APIs

Join us for this comprehensive and insightful exploration addressing the challenges and issues of  N-nitrosamine impurities in APIs and drug products.