Be Agilent Sure for Mutagenic Impurities

Analytical Solutions to Answer Regulatory Requirements

By Agilent On Feb 23, 2021

Solutions for Emerging Nitrosamine Contamination of Pharmaceuticals

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. And Metformin is under the same alert now.

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.

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