Genotoxic Impurities

Over the past decade or so, the issue of impurities present in pharmaceuticals which may be DNA-reactive has caused regulators and manufacturers significant problems.

This has been highlighted by the recall of various products throughout 2019 due to issues with NDMA.

Whilst there are tests for determining Carcinogenicity and Mutagenicity for safety labelling purposes, these generally lack the sensitivity to detect Genotoxic (i.e. the property of being able to damage cellular DNA and induce genetic mutations) impurities which are often only present at parts per million (ppm) levels.

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