Optimized method development strategies for the quantification of small and complex N-nitrosamines impurities

N-nitrosamines are potential carcinogenic impurities that can pose a risk to human health when exposed over an extended period.

Whilst global regulations are evolving, where there is risk of N-nitrosamine formation in drug products, analytical testing is still necessary. With this continues a requirement for customized and optimized sample extraction, chromatographic separation, and often flexible mass spectrometry acquisition, supporting a range of regulatory set threshold limits, for both small and complex N-nitrosamines.

Small and complex N-nitrosamines (NDSRI) present common challenges, such as extraction efficiency and robust detection, whether quantification is to the trace level or to higher limits of sensitivity. Specific challenges also arise, such as minimizing low mass interference for small N-nitrosamines or managing structural similarities to the API and isomeric separation for NDSRIs. Minimizing contamination and N-nitrosamine formation during sample preparation is always critical.

In this webinar, Dr. Padmakar Wagh, Associate Director: Applications at Waters Corporation and Hugo Cortés, a senior specialist in mass spectrometry at Waters Corporation, will demonstrate strategies for developing robust quantification assays for both small N-nitrosamines and NDSRI in drug products. They will address the typical challenges encountered for both types of N-nitrosamines, and will include practical examples of quality method development and take-away method development strategies from Waters laboratories.

Key learning objectives

• Understand the common and specific challenges in developing quantitation methods for small and complex (NDSRI) N-nitrosamines

• Discover new strategies for optimizing the sensitivity of N-nitrosamines detection in drug products by LC-MS

• Learn how to manage selectivity challenges in sample extraction and chromatography separation of small and complex N-nitrosamines

• Explore tools to increase efficiency and confidence in N-nitrosamines method development

Who should attend?

Analytical development laboratories and QC laboratories in the innovative and generic pharmaceutical industry, contract testing, and contract manufacturing to the pharmaceutical industry, laboratory managers, and senior scientists.

Presenter: Dr. Padmakar Wagh (Waters Corporation)

Dr. Padmakar Wagh has been working in his present role as Associate Director: Applications at Waters Corporation for the past 6 years. He has been responsible for managing Waters demo labs across India and has been actively involved in developing various applications including nitrosamines. Before joining Waters, he worked at various pharmaceutical companies in analytical research and development. He has a PhD in chromatography and is passionate about solving analytical challenges. He is also one of the founder members of a charitable hospital which serves the needy in the rural areas of India.

Presenter: Hugo Cortés (Waters Corporation)

Hugo Cortés is a senior specialist in mass spectrometry at Waters Corporation, a position he has held for 11 years. He attended the National Polytechnic Institute College of Biomedical Sciences in Mexico where he studied biochemical engineering. He has worked in analytical development in pharmaceutical, environmental, food safety, natural products research, metabolomics and toxicological analysis areas with Waters products for 20 years. He has participated in the development of methods for the analysis of nitrosamine together with regulatory entities in Mexico for four years.

Presenter: Ellen Simms (Assistant Editor, SelectScience)

Ellen studied biological sciences at the University of the West of England, UK, before completing a master's in epidemiology from the University of Bristol. As a member of the Editorial team, she now plays an integral role in shaping the content on SelectScience.