Difference between assay and purity regarding pharmaceutical analysis – Primer

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ARTICLES, APPNOTES, FAQ (9289)
- AppNotes Library (1888)
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- Frequently Asked Questions?? (3402)
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December 30, 2012
Bill Ciccone

ARTICLES, APPNOTES, FAQ / Frequently Asked Questions?? / General Information / HPLC Primer / HPLC Tips and Suggestions

According to the WikiAnswers website, an “assay” method provides an experimentally determined value for the content or potency of an analyte in a sample.

In contrast, a “purity” methods provides an accurate quantitative statement of all impurities in a pharmaceutical sample.

This includes related substances, residual solvents, etc. Please refer to the International Conference on Harmonization (ICH) guidelines for more detail.

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