Potency Testing
TestingAlso known as: Assay testing, Quantitative analysis, Active ingredient quantification
Testing to verify the amount of active ingredients matches label claims.
What It Means
Potency testing quantifies the amount of active ingredients in a product to verify label accuracy. Methods include HPLC, UV-Vis spectroscopy, and titration depending on the ingredient. Under 21 CFR Part 111, finished product must meet specifications for each active ingredient listed on the label, within established variability ranges.
What It Is Not
Potency testing verifies AMOUNT, not identity or purity. A product can pass potency testing while containing contaminants. Potency results are a snapshot of one batch — they do not guarantee consistency across production runs.
Evidence and References
- regulation21 CFR 111.320-325 finished product specs
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