Control Strategies and Method Development for Nitrosamines in APIs and Drug Products

Learn how to navigate the regulatory landscape utilizing current method development technologies for impurity control in late-phase API manufacturing.

Register Free: https://www.chromatographyonline.com/lcgc_w/control-strategies

Event Overview:

This webinar will cover the method development strategies for control of nitrosamines in drug substances and drug products. There will be a focus on platform method development across liquid chromatography-tandem mass spectrometry (LC-MS-MS), high-resolution LC-MS, and gas chromatography-mass spectrometry (GC-MS), and application of these methods to challenging drug substances and drug products. The webinar will include a review of method development and validation case studies for nitrosamines of concerns, as well as strategies for drug-derived nitrosamines to ensure you bring your drugs into compliance ahead of the August 2025 deadline.

Key Learning Objectives

• Discuss the regulatory landscape for nitrosamines and nitrosamine drug substance-related impurities (NDSRIs)
• Learn to select the right analytical technologies for nitrosamines assessment
• Understand different method development and validation strategies

Who Should Attend

• Chemistry manufacturing control (CMC) and regulatory leaders
• Analytical scientists working in method development
• Scientists with an interest in the determination of drug substance and product nitrosamines control
• Scientists with an interest in high-performance liquid chromatography (HPLC) or GC separations and MS
• Procurement and sourcing managers in the pharmaceutical industry

Speaker

Shankar Sankaran
Director, Analytical
SK pharmteco

Shankar Sankaran is director of analytical at SK pharmteco, where he oversees method development, validation, release testing, stability studies, and reference standard management for both CDMO operations and contract analytical services. With over 16 years at the organization, Shankar previously worked as a laboratory chemist, and has taken on increasing responsibilities in quality control and method development to support API programs from early to late phases and into commercial stages.

Register Free: https://www.chromatographyonline.com/lcgc_w/control-strategies