Senior Research Scientist (Pharmacologist) US Food and Drug Administration Silver Spring, Maryland
Nitrosamine compounds are carcinogenic and are potential high-risk impurities in drug products. These impurities are labeled ubiquitous as multiple reports outlined the many possible root causes of their formation during the manufacturing process highlighting the complex challenges associated with mitigating their risk. One approach in controlling the levels of these impurities in bumetanide drug products is using antioxidants and pH modifiers in the formulations. The primary objective of this work is to mitigate the risk of formation of N-nitrosamine impurity by evaluating the role of different antioxidant inhibitors in different formulations prepared in-house by CDER formulation scientists using bumetanide as a model drug.
Learning Objectives:
Understands the nitrosamine formation in drug products, possible mitigation strategies, and analytical challenges.
Understands the changes in manufacturing process of drug product can affect the nitrosamine mitigation
Understands the Fit-For-Purpose mitigation strategies for each drug product