Nitrosamines are chemical compounds classified as probable human carcinogens on the basis of animal studies. Since 2018, an increasing number of nitrosamine impurities, including N-nitrosodimethylamine (NDMA), were found in a chemically related group of antihypertensive drugs known as ‘sartans’. Subsequently, a nitrosamine impurity was detected in batches of ranitidine, a medicine used to treat heartburn and stomach ulcers and chemically unrelated to sartans.
This led to some product recalls and to an EMA review under article 5(3) of Regulation (EC) No 726/2004 to provide guidance to marketing authorization holders on how to avoid the presence of nitrosamine impurities in human medicines. As part of this review, the CHMP has requested marketing authorization holders for human medicines containing chemically synthesized active substances to review their medicines for the possible presence of nitrosamines and test all products at risk.
High sensitivity and precise quantification in your routine nitrosamine impurities analysis.
Delivering full-spectrum, high-resolution, accurate-mass data for screening, profiling and quantifying your nitrosamines impurities to required LOD’s.
Affordability for testing nitrosamines impurities commonly found recently.
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