DUNS Number - 67-716-4521



Pharma / Bio Pharma

Crop Care




Impurity / Metabolite Qualification

Impurity / Metabolite Qualification

Qualification is the process of acquiring and evaluating data that establishes the biological safety of an individual impurity or a given impurity profile at the level(s) specified.

The level of any impurity present in a new drug substance that has been adequately tested in safety and/or clinical studies would be considered qualified. Impurities that are also significant metabolites present in animal and/or human studies are generally considered qualified.


It is also equally important to isolate, characterize and evaluate the tissue specific accumulation / clearance of a potential metabolite, under the human metabolic clearance mechanisms. The next phase involves evaluation of genotoxicity potential as well as mammalian toxicity of such metabolites.

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