Join us for an insightful webinar exploring advanced LC-MS/MS approaches for the quantitative analysis of nitrosamine impurities using the SCIEX novus V55 system.

This session will highlight highly sensitive and selective LC-MS/MS workflows for the detection and quantitation of trace-level nitrosamine impurities in pharmaceutical products. Learn about optimized sample preparation, chromatographic separation, and MRM-based quantitation strategies designed to deliver accurate, reproducible, and regulatory-compliant results.

The webinar will also cover method development and validation considerations, analytical challenges associated with nitrosamine analysis, and best practices to support global regulatory requirements for routine quality control and risk assessment.

Speakers

Dr. Dev Kant Shandilya

Director - Analytical Research and Development, Fresenius Kabi

Dr. Devkant is an accomplished analytical chemistry leader with over 26 years of experience in pharmaceutical analytical R&D, specializing in APIs, drug products, peptides, and complex generics. He has extensive expertise in LC-MS/MS, impurity profiling, nitrosamine and elemental impurity analysis, method development and validation, and regulatory submissions (DMF, NDA, and ANDA). Holding a Ph.D. in Chemistry, an MBA, and an M.Sc. in Analytical Chemistry, Dr. Devkant has successfully led high-performing analytical teams and driven innovation in pharmaceutical development and regulatory compliance.

Topic:
LC-MS-Based Quantitative Analysis of Nitrosamines from Leachable

Key Highlights:

• Ultra-trace detection and quantitation of nitrosamines using highly sensitive LC-MS methodologies.
• Optimized sample preparation and chromatographic separation for enhanced selectivity and analytical robustness.
• Validated workflows supporting regulatory-compliant risk assessment of nitrosamine impurities arising from leachable sources.

Aman Sharma

Sales Development Manager, Sciex India Pvt Ltd

Aman Sharma has over 18 years of experience in analytical sciences, spanning analytical instrumentation, application support, and strategic marketing. He specializes in understanding market needs, driving demand generation, and developing innovative marketing initiatives. Known for his strategic mindset, customer-centric approach, and collaborative leadership, he has successfully bridged technical expertise with business growth.

Topic:

High-Sensitivity Quantitation of Nitrosamine Impurities with the SCIEX novus V55 system

Key Highlights:

• Enhanced sensitivity for low-level nitrosamine detection.
• Robust quantitative performance with optimized LC-MS/MS workflows.
• Streamlined method development for routine quality control and regulatory compliance.