This presentation will provide a comprehensive overview of the detection, quantification, and regulatory implications of nitrosamine impurities in pharmaceuticals, with a focus on advancements in liquid chromatography-mass spectrometry (LC-MS) techniques. Given the potential carcinogenic risks associated with nitrosamines, regulatory agencies such as the FDA and EMA have imposed stringent guidelines, necessitating highly sensitive and reliable analytical methods for impurity monitoring.
The session will begin by exploring the chemical origins and pathways of nitrosamine formation during drug synthesis, storage, and degradation. It will then delve into state-of-the-art LC-MS methodologies used for detecting these impurities at ultra-trace levels, highlighting key challenges in method development, validation, and regulatory compliance.
Additionally, the presentation will address the evolving regulatory landscape, including the harmonization efforts under ICH M7 and challenges faced by pharmaceutical manufacturers in meeting these requirements. Practical case studies will be discussed to illustrate real-world challenges in nitrosamine detection and mitigation.
Finally, emerging technologies such as predictive modeling, real-time monitoring, and AI-driven data analytics will be explored as potential solutions to enhance impurity control strategies. By the end of the session, attendees will have a deeper understanding of the current gaps in nitrosamine detection and regulatory compliance, as well as the future directions for ensuring drug safety and efficacy.
Learning Objectives:
Learn about the chemical origins, formation pathways, and genotoxic risks of nitrosamine impurities in pharmaceuticals, emphasizing their potential carcinogenic effects and impact on drug safety and efficacy.
Gain insights into liquid chromatography-mass spectrometry (LC-MS) methodologies for detecting and quantifying nitrosamines at trace levels, addressing analytical challenges, method validation, and regulatory compliance in pharmaceutical quality control.
Examine the evolving regulatory landscape, including FDA, EMA, and ICH guidelines, and identify key challenges in risk assessment, analytical method implementation, and mitigation strategies for nitrosamine impurities in pharmaceutical manufacturing.
