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Assay is the quantitative determination of the amount of a component in a sample.

Purity is the determination of the impurities in the sample. It can be quantitative, semi-quantitative or qualitative.

For example : if you dissolve 4 grams of compound A (with no impurities in it) in 6 grams of water, you get a solution of compound A with 100% purity and 40% assay.

From the ICH Guideline Q2A (Validation of Analytical methods) :

"- Testing for impurities can be either a quantitative test or a limit test for the impurity in a sample. Either test is intended to accurately reflect the purity characteristics of the sample. [...]

- Assay procedures are intended to measure the analyte present in a given sample. In the context of this document, the assay represents a quantitative measurement of the major component(s) in the drug substance."

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What is the difference between assay on as is basis and assay on anhydrous basis?

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An assay is a scientific test or analysis used to measure the presence, amount, or activity of a substance or compound in a sample. Assays are commonly used in biology, chemistry, and medicine to study a wide range of biological and chemical processes.


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In biochemistry, an endpoint assay measures the final amount of a product formed or substrate remaining after a reaction has stopped, providing a single data point. A kinetic assay, on the other hand, measures the rate of a reaction by recording multiple data points over time. Kinetic assays provide additional information about reaction mechanisms, enzyme activity, and inhibitor kinetics compared to endpoint assays.


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