Nitrosamine
An organic compound containing the N-N=O group, formed when a secondary or tertiary amine reacts with a nitrosating agent such as nitrite under acidic conditions. Many nitrosamines are potent mutagenic carcinogens. Regulators require drug makers to assess and test for them, including nitrosamine drug substance-related impurities that arise from the API structure itself, using sensitive mass spectrometric methods.
Related terms
Deuterated Compound
A compound in which one or more hydrogen atoms have been replaced by deuterium, the stable hydrogen isotope w…
Genotoxic Impurity
An impurity that can damage DNA and potentially cause mutations or cancer, even at very low levels. Such impu…
ICH M7
The ICH guideline on assessment and control of DNA-reactive, potentially mutagenic impurities in pharmaceutic…
Reference Standard
A highly characterised material used as a benchmark to confirm identity, measure assay or quantify impurities…
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