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  • Session 1: Tuesday, February 20, 2024 at 7am PST | 10am EST | 4pm CET
  • Session 2: Tuesday, February 20, 2024 at 11am PST | 2pm EST



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High-Sensitivity Quantitation of Nitrosamine Impurities and NDSRI in Drug Substances and Products Using LC-MS/MS

Event Overview:

Nitrosamine impurities are classified as “cohort of concern” per ICH-M7 guidelines. There have been numerous drug recalls since 2018 including several sartan, ranitidine and metformin, varenicline-based drugs due to the presence of unacceptable levels of nitrosamines. Since then, nitrosamines and more recently, nitroso drug substance related impurity (NDSRIs) contamination in drugs is of increased concern by regulators as it poses significant health risks. According to the recent guidance published by both the FDA and EMA, nitrosamines and NDSRIs must be monitored at the low ng/mL using highly sensitive analytical methodologies. LC-MS/MS is inherently a selective and sensitive analytical technique that is well-suited for identification and quantification of nitrosamines at very low levels.

In this presentation, we will cover the accurate determination and quantitation of nitrosamine impurities and NDSRIs in drug substances and products using LC-MS/MS based analytical strategies that can readily be adopted.

Key Learning Objectives:
  • Understand what mutagenic impurities are and the importance of characterization and quantitation
  • Learn about an improved Multi Residue Method (MRM) for comprehensive analysis of 8 nitrosamines in losartan drug product using the Agilent 6495LC/TQ system
  • Learn about a sensitive and robust MRM method to quantify NDSRIs in various drug substances and products using the Agilent 6475 and 6495 LC/TQ systems
Who Should Attend:
  • Laboratory managers
  • Chromatographers
  • Analytical chemists and scientists
  • New product developers
  • Pharma manufacturing and quality control managers
Featured Speakers:

Lee Bertram
Lee Bertram
Application Development Engineer
Agilent Technologies


Lee is an application scientist at Agilent with a focus on development of methods for LC/SQ, LC/TQ and LC/Q-TOF within the pharmaceutical products. He has over 10 years of method development experience ranging from large/small molecule pharmaceutics to cellular metabolomics method development.
Prasanth Joseph
Prasanth Joseph
Application Engineer
Agilent Technologies


Prasanth joined Agilent in 2015 as an application engineer developing LC-MS/MS methods for pharmaceuticals.   He has 20 years of experience in the analytical instrumentation industry, specializing in small molecule applications including E&L, mutagenic impurities analysis and ADME and PK related studies.

For any technical questions, please contact Nicole Valle: nvalle@mjhevents.com