Managing the complexities of NDSRI method development: The N-nitroso propranolol case story

With the latest regulatory updates encompassing a pragmatic and structural related approach to determining the risk of N-nitrosamine impurities in pharmaceuticals, there remains the ongoing need for pharmaceutical manufacturers to consistently mitigate and control levels of these impurities in new and existing products. When required, analytical testing plays an important role in ensuring levels remain below regulatory acceptance thresholds.

In this webinar, Marian Twohig, Ph.D, Principal Scientist at Waters Corporation, will provide an overview of the more recent progress around N-nitrosamines regulations. Driven by the latest regulatory guidelines, Marian will share a comprehensive overview of the development of an analytical methodology for the quantification of N-nitroso propranolol in propranolol, citing unexpected challenges and the resolutions that lead to robust method optimization beyond regulatory required thresholds.

Key learning objectives:

• Align analytical method optimization to current regulatory guidance.
• The importance of high-quality chromatographic methods to facilitate ease of API and isomeric impurity resolution.
• Accessible approaches in tandem quadrupole mass spectrometry solutions supporting the investigation and tentative identification of unexpected peaks and other method optimization challenges.

Who should attend?

Those working in pharmaceutical analytical development, pharmaceutical QA/QC, and regulatory in innovative and generic pharma, contract testing, and research and manufacturing organizations (CTO, CRO, CDMO).

Certificate of attendance

All webinar participants can request a certificate of attendance, including a learning outcomes summary, for continuing education purposes.

Presenter: Dr. Marian Twohig (Principal Scientist, Waters Corporation)

Marian Twohig is a scientist with a passion for problem solving using analytical instrumentation. She has over 18 years of experience supporting quantitative and qualitative applications in the pharmaceutical, food and environmental and materials science industries. She works as a Principal Scientist for Waters Corporation where she has previously held several Senior Scientist positions.