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7 Apr 2020

What is the difference between purity and potency?

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Purity means relative freedom from extraneous matter in the finished product, whether or not harmful to the recipient or deleterious to the product. Purity includes but is not limited to relative freedom from residual moisture or other volatile substances and pyrogenic substances.

The word potency is interpreted to mean the specific ability or capacity of the product, as indicated by appropriate laboratory tests, to yield a given result.

KPE-C-103 Executive Program in Global Drug Regulatory Affairs [EPGDRA]

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