The next frontier in nitrosamine testing: detection and risk assessment in packaging and IV infusion bags

Register for the webinar today. Wednesday, September 23, 2026 at 10:00am (EDT).

The regulatory and analytical landscape for nitrosamine testing continues to evolve, placing increasing demands on pharmaceutical manufacturers and analytical laboratories. Nitrosamine analysis has pushed the analytical lab to reach new levels of sensitivity, requiring highly sensitive and robust analytical methods to detect impurities at very low levels. As regulatory expectations develop, the scope of nitrosamine risk assessment is also expanding to consider potential sources such as extractables and leachables from pharmaceutical packaging.

In this Waters Corporation webinar, Jason Brown, expert in nitrosamine testing and regulation, and Dr Marian Twohig, Consulting Scientist at Waters Corporation, share their perspectives on the current state of nitrosamine concerns, detection and risk assessment. They will also discuss nitrosamine risk in relation to extractables and leachables from packaging materials such as IV infusion bags.

Topics covered will include the intersection of nitrosamines with extractables and leachables and other N-nitroso species (o-NNOs), alongside the evolving nitrosamines landscape and what Nitrosamine Limits 2.0 could look like.

The webinar will also cover liquid chromatography-tandem mass spectrometry (LC-MS/MS) methodologies that can help achieve regulatory limits for small dialkyl nitrosamines, with a focus on strategies for addressing persistent interfering chromatographic peaks from solvents, as well as the importance of optimising LC and MS parameters to achieve the required levels of sensitivity.

This will be followed by a fireside chat to discuss the past, present and future of nitrosamine testing.

What you will learn

• Understand the evolving regulatory and analytical landscape for nitrosamine testing.
• Strategies to optimize LC and MS parameters to mitigate analytical challenges associated with small dialkyl nitrosamine quantification.
• Explore tools and technologies that can help accelerate LC-MS/MS method development.

Who should attend

• Research Associates
• Scientists
• Senior Scientists
• Principal Scientists
• Directors
• Lab Managers