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.
Investing in a new LC-MS system is not an easy decision, especially if you have a range of analytical requirements in your laboratory. This blog is part of a series intended to help you choose the right system for your pharmaceutical research and development needs.
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??
I am Using Sciex Qtrap 4500 for quantification of nitrosamines (NDMA&NDBA). I am facing issue with higher baseline intensity. When developed the method in APCI the basline was at about 5e4. but now even after cleaning the source (i.e. Changed capillary to new, Curtain plate & Corona needle cleaning, given blank injection overnight ), my base line decreased from 1e6 to 4 e5, but settled at 4 e5 from past 24 hours. can you suggest me how decrease my baseline intensity further to below 1e5. My standard peaks are like noise now.
At SCIEX, we are proud to provide analytical systems to the pharmaceutical industry. We work hard to understand the demands of analytical work and the processes required to develop and manufacture drugs.
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