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Optimizing Pharmaceutical Formulations: Strategies for Improving Stability and Minimizing Nitrosamine Impurities

Published January 27, 2026

Resource Pharma

10 June 2025

Speakers

 

Amit Chivate

Ph.D., MBA, Senior Area Marketing Manager for Greater Asia and China at Roquette

Cynthia Ciliberto

Ph.D., Director of Global Regulatory Affairs at Catalent

Experts from Roquette and Catalent join Pharma Excipients for an informative webinar about nitrosamine mitigation strategies.

 

Nitrosamine impurities continue to present significant challenges to pharmaceutical safety and regulatory compliance, with direct implications for patient health. In this webinar, we will explore a set of effective, science-driven strategies to mitigate nitrosamine risks throughout the product lifecycle.

 

What you’ll learn:

 

  • A three-pronged mitigation strategy to reduce nitrosamine risk
  • How Roquette’s low-nitrite excipient portfolio supports safer formulations
  • The role of excipients in nitrosative potential and nitrosatable amines
  • Navigating regulatory expectations—including health authority queries
  • Integrating risk reduction into early-phase clinical development ensuring your products meet global safety standards while protecting patients—starting at the excipient level.

 

Watch now