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WHAT IS THE DIFFERENT BETWEEN PURITY, POTENCY AND ASSAY
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Answer Posted / ravi a
Potency is a measure of the activity of a drug in a biological system & assay is analysis of drug to determine the presence, absence, or quantity of one or more components.
A purity test is to ensure that all the analytical procedures performed allow an accurate statement of the content of impurities of an analyte, i.e. related substances test, heavy metals, residual solvents content, etc.
Assay: to provide an exact result which allows an accurate statement on the content or potency of the analyte in a sample.
u can find answer in International conference on Harmonisation(ICH)(2005) online edition:)
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