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Regulatory agencies require pharmaceutical drug developers to identify and provide a mechanistic rationale for observing impurities or degradation products arising from stability studies under recommended storage conditions. Moreover, the impurities in drug products can be attributed not only to the drug substance or inert ingredients used for formulating a drug product; but they can also be brought into the drug product through formulation process or contact with packaging of various impurities that can be found in drug products.

Pharma Inventors are highly experienced in analyzing and synthesizing such process impurities or metabolites of drug substances that are critical in drug development research and to expedite your ADME-TOX and mechanism of action studies.