Nitrosamines Beyond Compliance: Practical Strategies and Real-World Case Studies
Day 2 Manufacturing 5.0 Stage
07/10/2026 15:15 - 15:40pm
Contributors
Emiliano De Dominicis : Chemistry Research Director - Mérieux NutriSciences
As nitrosamine risk assessment has become an established part of pharmaceutical development and quality control, the focus is now shifting towards the analytical challenges associated with reliable detection, result interpretation and robust root cause investigation. This presentation will explore practical aspects of nitrosamine testing through a series of real-world case studies derived from routine laboratory experience.
Topics will include LOQ verification in highly contaminated samples, analytical nitrosation and the impact of scavengers and water, nitrite contamination in raw materials, API and finished products, and strategies to distinguish genuine contamination from artefact formation. The session will also discuss practical considerations for method development and GMP validation, providing actionable insights to improve data reliability, support scientifically sound decisions and strengthen nitrosamine control throughout the pharmaceutical product lifecycle.