Free Webinar | Nitrosamine Risk in Pharmaceuticals
Nitrosamine Risk in Pharmaceuticals: Regulatory Expectations and Analytical Strategies
Nitrosamine impurities remain a major and evolving regulatory challenge for pharmaceutical manufacturers. With the introduction of NDSRIs and new confirmatory testing requirements, expectations from authorities have significantly increased. Marketing Authorization Holders (MAHs) and manufacturers must now implement comprehensive strategies that cover risk assessment, confirmatory testing, and lifecycle management, combining analytical and regulatory expertise.
To support pharmaceutical companies in addressing these evolving requirements, Mérieux NutriSciences | Pharma & Healthcare provides scientific expertise and advanced analytical solutions covering nitrosamine risk assessment, confirmatory testing, and lifecycle management.
Join our Webinar!
The Webinar:
During this technical-regulatory webinar, Emiliano De Dominicis, Chemistry Research Director, will present a structured approach to nitrosamine risk management, addressing current regulatory expectations and practical implementation strategies. The session will discuss risk evaluation methodologies, confirmatory testing strategies, and analytical challenges associated with both small nitrosamines and NDSRIs.
Particular attention will be given to:
- Regulatory justification strategies
- NAP test applications for nitrosation risk evaluation
- Nitrite assessment in APIs, excipients, and drug products
- Method development considerations for nitrosamine analysis
Our Expert:
Emiliano De Dominicis
Chemistry Research Director
Mérieux NutriSciences – Italy
Related Content
Read more on nitrosamine risks and our solutions for the pharmaceutical industry
