COA (Certificate of Analysis)
TestingAlso known as: Certificate of Analysis, C of A, Analytical Certificate
A document reporting test results for a specific batch of ingredients or finished product.
What It Means
A Certificate of Analysis is a document issued by a testing laboratory reporting the results of testing performed on a specific batch or lot. For supplements, COAs typically cover identity, potency, purity, and contaminants (heavy metals, microbes, pesticides). 21 CFR Part 111 requires manufacturers to verify the identity of incoming ingredients, and COAs from suppliers are a common (but not always sufficient) method.
What It Is Not
A COA from a supplier is NOT a substitute for the manufacturer's own identity testing under Part 111 (though an exemption exists for specific conditions). COAs can be falsified — the testing lab matters as much as the document. A COA for one batch does not guarantee another batch meets the same specifications.
Evidence and References
- regulation21 CFR 111.75 identity testing requirements
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