Overcoming the Challenges of Nitrosamine Impurities in Drugs

The challenges for analytical science laboratories performing nitrosamine analysis relate to high sensitivity that must be achieved to fulfill the regulation requirements, and selectivity that is critical to avoid false positive non-compliant results. It is essential to analyze nitrosamines that can accidentally occur in pharmaceutical products as they are carcinogen impurities. The limits imposed by the current regulations are stringent and could potentially be lowered in the future to ensure patients safety. In this webinar, we will discuss the Thermo Fisher Scientific GC-MS solutions that help analytical laboratories to overcome the challenges of nitrosamine analysis. We will look at targeted quantitation using GC-MS and GC-MS/MS coupled with headspace sampling and high-resolution accurate mass using accurate mass confirmation of nitrosamines, allowing expanded scope of analysis and retrospective analysis of samples.

Key learning objectives:

• Overview of nitrosamine impurities and the risk to human health
• U.S. FDA current regulations for nitrosamine analysis
• Targeted approach for nitrosamine analysis according to U.S. FDA methods
• Untargeted approach for the determination of nitrosamines and other volatile impurities with Thermo Scientific Orbitrap technology and headspace sampling

Who should attend:

• Analysts and laboratory managers working in reference and analytical testing labs
• Scientists and chemists in pharmaceutical testing laboratories
• Analysts performing nitrosamine analysis