Literature review evaluates risk assessment and analytical strategies for genotoxic impurities in drug compounds, highlighting regulatory frameworks for pharmaceutical safety.
The present work is based on a assess analysis of the literature in order to define the genotoxic impurities present in the drug substances and drug products. Starting from the definition of genotoxic impurities, sources of genotoxic impurities, their generation and classification based on their toxicity. The article also explains the various regulatory guidelines to control the genotoxic impurities in drug substances. Isolation, qualification of impurity and its identification along with quantification by the various analytical methods is also described in this review article.
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Tabrez Shaikh (2018) studied this question.
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