Utilizing A Stepwise Approach For Nitrosamine Risk Mitigation

Since the introduction of mandatory nitrosamine testing in 2018, along with evolving regulatory requirements, drug developers have faced increasing pressure to meet high standards for selectivity and sensitivity in impurity detection. Nitrosamines can form during both active pharmaceutical ingredient (API) and drug product manufacturing, raising critical questions about the optimal timing and strategy for impurity analysis.

In this presentation, Cambrex expert Todd Sprouse, Associate Director of Analytical Services, shares practical insights and case studies demonstrating how a tailored, stepwise testing approach can effectively detect, quantify, and control nitrosamine impurities while maintaining cost efficiency. Key topics include risk assessment strategies, evaluation of nitrosamine formation potential under typical manufacturing conditions, development of sensitive analytical methods, and mitigation techniques such as nitrate testing of APIs, raw materials, and excipients.