N-nitrosamine analysis has raised significant concerns in the pharmaceutical industry since 2018, when these potential carcinogens were found in several angiotensin II receptor blockers (sartans). Subsequent discoveries in ranitidine and some slow-release metformin medications prompted widespread product recalls. The industry has implemented stricter manufacturing requirements and intensified efforts to evaluate and control N-nitrosamine contamination. To meet stringent regulatory requirements, it is essential to develop effective chromatography and mass spectrometry (MS) methods for N-nitrosamine analysis. This blog addresses the challenges associated with detecting N-nitrosodimethylamine (NDMA) in metformin drug products.
Pharma
From small molecule metabolism, bioanalysis quantification, to early ADME, find out how today's top researchers spend their day using mass spectrometry to drive the drug discovery pipeline. Because every day is a different day in drug research.
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N-Methyl Pyrollidone
I am in the process of analyzing nitrosamines using QTRAP. One of the difficulties in my sample preparation would be using NMP as solvent to dissolve the material. Is it safe to inject approximately 10ul of NMP is QTRAP??

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SCIEX was very proud to have an illustration of the Acoustic Ejection Mass Spectrometry (AEMS) technology that powers the Echo® MS system on the front cover of the Journal of the American Society for Mass Spectrometry in January 2023. The associated article—Ultrahigh-Throughput Intact Protein Analysis with Acoustic Ejection Mass Spectrometry—was co-authored by scientists from SCIEX and Merck.
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What have we learned from the nitrosamine crisis?
The pharmaceutical industry is facing an ongoing issue with genotoxic impurities (GTIs). Over the past year, we have witnessed genotoxic impurities affect several drugs, including those used to treat elevated blood pressure, heartburn and acid reflux. Angiotensin II...
Top 7 Echo® MS system customer questions—answered
You asked, we answered! With analysis speeds of at least 1 sample per second, the Echo® MS system has created a buzz in the industry. This is up to 50x faster than conventional LC-MS/MS. This revolutionary tool for drug discovery and development has led to...