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

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.

Register Free: https://www.chromatographyonline.com/lcgc_w/nitrosamine-impurities

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 these poses significant risk to human health. 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 for comprehensive analysis of 8 nitrosamines in losartan drug product using the Agilent 6495LC/TQ system.
• Learn about a sensitive and robust Multi Residue 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

Speakers

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
Application Engineer
Agilent Technologies

Prasanth Joseph joined in Agilent in 2015 as application Engineer for LC-MS/MS and has 20 years of experience in the analytical instrumentation industry, specialized in small molecule applications. Prasanth received his master’s degree from Cochin University of Science and Technology and a Ph.D. in Environmental Science from Bharathiar University, India. He also has master’s degree in business administration from the University of Buckingham, UK.

Prasanth developed many analytical methods in LC-MS/MS to quantify genotoxic impurities in drug substance and products, analysis of extractables and leachables in pharma and food packaging & medical devices and Bioavailability and Bioequivalence (BA/BE) studies in clinical trials. He provides guidance in developing LC-MS workflows for impurity profiling of pharmaceuticals and metabolite identification (MetID) and quantification as a part of ADME/DMPK related studies. Prasanth is also well versed with analysis of phytochemicals in botanicals and herbal extracts, food residue screening and quantitation and analysis of contaminants in environmental samples.

Prasanth is the author of many application notes and coauthor in various publications and presented many technical posters in various forums such as ASMS and AOAC.

Register Free: https://www.chromatographyonline.com/lcgc_w/nitrosamine-impurities