Genotoxic Impurities

Impurities are classified as
1. Organic impurities
2. Inorganic impurities
3. Residual solvents etc
International body, ICH, has provided set of regulatory guidelines to set limits for the above impurities based on toxicity studies of the drugs and the maximum daily dosage of the drugs.
However, some of the impurities if present in trace levels, can modify gene mutation in the human body and hence considered as toxic and are called as genotoxic impurities.

A presentation on genotoxic impurities, guidelines of US, Europe, setting limits etc. are explained in detail.



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