Senior Research Scientist US FDA St. Louis, Missouri
Nitrosamine drug substance related impurities (NDSRIs) has emerged as significant safety and quality concerns for pharmaceutical products, necessitating risk assessment and the development of effective control and mitigation strategies. Analytical procedures play a pivotal role in these strategies, offering insights into the presence and levels of NDSRIs. Through case studies, this presentation discusses complexities and challenges involved in developing an analytical procedure for NDSRI analysis and explores the strategies that can be employed to navigate these challenges to meet the needs of detecting and quantitating these trace level impurities.
Learning Objectives:
Upon completion, participants will be able to understand better the complexity and challenges in the development of analytical methods for NDSRI analysis.
Upon completion, participants will be able to identify potential causes contributing to these challenges and explore various strategies and tools for effectively addressing them.
Upon completion, participants will be able to apply the learned strategies and tools in the development of analytical methods for NDSRI analysis for their projects.
