The Next Frontier in Nitrosamines Testing: Detection and Risk Assessment in Packaging and IV Infusion Bags

The Regulatory and Analytical Landscape for Nitrosamines Testing continues to evolve.

In this webinar, we bring together Jason Brown, a recognized leader in the world of Nitrosamines testing and regulations, and Dr. Marian Twohig, Consulting Scientist, Waters Corporation, to share their perspectives on the current state of nitrosamines concerns and how those concerns now extend to E&L from packaging material like IV bags, followed by a fireside chat to discuss the past, the present and what comes next.

Nitrosamine analysis has pushed the analytical lab to reach new levels of sensitivity.

Jason Brown will discuss the intersection of Nitrosamines with Extractables and Leachables to o-NNO's (other N-Nitroso Species). What does the evolving landscape for nitrosamines mean and what do Nitrosamines Limits 2.0 look like?

Marian Twohig will describe the challenges and LC-MS/MS methodologies that can help achieve the regulatory limits for small dialkyl nitrosamines. She will address strategies to address persistent interfering chromatographic peaks from solvents and the importance of optimizing every LC and MS parameter to achieve required levels of sensitivity.

What you’ll gain from this session

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

Who should attend

This webinar is designed for Research Associates, Scientists, Senior Scientists, Principal Scientists, Directors, and Lab Managers.

Don't miss it!

Presenter: Jason Brown (Consultant, SCxCMC / Brown Pharma Consulting)

Jason Brown is an experienced end-to-end nitrosamine expert and analytical CMC leader with proven knowledge in nitrosamine risk assessments, structural identification, analytical techniques, root cause analysis, reformulation, and control strategies.

He authored July 2025 AAPS Newsmagazine Cover Article, "Nitrosamine Control Strategies: From Risk Identification to Implementation."

Jason is a recognized innovator with a patent application for reformulation techniques and research articles concerning inhibition techniques and gastric nitrosamine formation in addition to numerous panel discussions, speakerships, posters, articles, and co-host of the USP Nitrosamine Conversations.

Presenter: Marian Twohig, Ph.D. (Consultant Scientist, Waters Corporation)

Marian has over 25 years of experience supporting quantitative and qualitative applications in the pharmaceutical, food and environmental and materials science industries.

She works as a Consulting Scientist for Waters Corporation where she has previously held several Senior Scientist positions. Currently, the focus of Marian’s work involves the development of quantitative analytical methods to meet the needs of the pharmaceutical industry.

She is particularly interested in chromatographic separations, and the application of combining low- and high-resolution mass spectral data with other chemical information for the identification of unknown chemical entities.

Marian holds a Ph.D. in Analytical Chemistry from Munster Technological University.