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Nitrosamine Impurities

List of '525' Nitrosamine Compounds

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What are Nitrosamine Impurities?


Nitrosamine Impurities are one of the common and unwelcome guests in the world of consumer goods and pharmaceuticals. Awareness of nitrosamine impurities began with the Sartans (e.g., Valsartan), but contaminants have been found in other popular products, as well.

More cases of Nitrosamine-contaminated drug substances and drug product batches have since been reported. A recall of drug products containing ranitidine, a histamine H2 receptor blocker, was issued in the United States. The EMA is also reviewing these products, and has urged manufacturers to test drug products containing pioglitazone, an insulin sensitizer, as well as metformin, which is found in diabetes medications. Recalls and additional reviews are being conducted.

Beyond the obvious, the pharmaceutical industry must recognise that the quality of reagents and solvents, even those used relatively early in the manufacturing process, is critical for ensuring the quality of the final drug substance. Clearsynth is helping Pharmaceutical industry and regulatory authorities with standards and testing solutions for risk assessment of nitrosamine related impurities.