The difference between potency and purity in drug products - Tips & Suggestions
March 15, 2013
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Please refer to the International Conference on Harmonization (ICH) guidelines for more detail.
A quick definition would be:
-Potency is a measure of drug activity expressed in terms of the amount required to produce an effect of given intensity.
-Purity is a measure of the amount of API present in a sample compared to those of related substances, impurities, residual solvents, etc.
A quick definition would be:
-Potency is a measure of drug activity expressed in terms of the amount required to produce an effect of given intensity.
-Purity is a measure of the amount of API present in a sample compared to those of related substances, impurities, residual solvents, etc.