Webinar Date/Time: Wed, Dec 11, 2024 11:00 AM EST
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 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:
Who Should Attend:
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
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