Nitrosamines have become a priority concern for regulatory authorities worldwide due to their potential carcinogenic risk, even at trace levels. Under ICH M7, pharmaceutical developers are expected to conduct thorough risk assessments, implement effective controls, and document their approach to managing these impurities. For many organizations, navigating these requirements can be complex and highly technical.

In this expert Q&A, Ardena’s CMC specialists Karel Aelvoet, Ph.D., Joost Steverlynck, Ph.D., and Bram Ach, Ph.D., share practical insights on how to evaluate nitrosamine risks, apply analytical methods, and use frameworks like CPCA to set acceptable intake limits.

Open the document to learn how regulators view nitrosamines, what strategies are recommended, and how to prepare your development programs for compliance