What is a Certificate of Analysis (COA)?

Definition: a Certificate of Analysis (COA) is a document, backed by laboratory testing, that reports the tests performed on a specific lot of a product, the results, and whether each result met its acceptance specification. For compounded sterile preparations, the tests that matter most are identity, potency, sterility, and bacterial endotoxin.

What a COA contains

A complete COA for a compounded peptide preparation typically identifies:

Product and lot number — the exact batch the results belong to. No lot number, no traceability.
Testing laboratory — the named lab that performed the analysis, with contact information.
Test date and beyond-use date (BUD) — when testing happened and how long the preparation is considered usable.
Identity and potency — confirmation the substance is what the label says, at the labeled strength, usually by HPLC or similar validated methods.
Sterility — for injectables, testing consistent with USP <71>.
Bacterial endotoxin — testing consistent with USP <85>, reported against a limit.
Appearance — visual description of the preparation.

Who issues a COA

The analytical work is done by a laboratory — either the pharmacy's own quality lab or an independent contract lab (see who tests compounded peptides). The COA itself is assembled for a lot by the pharmacy or manufacturer that released it. That distinction matters when you verify: the document you were handed should trace back to a named lab that will confirm it issued those results.

Why COAs matter for compounded peptides

Compounded preparations are made per-batch rather than in continuously validated mass production, so lot-level testing is the main written evidence that a given batch was checked. In a market where counterfeit paperwork is cheap to produce, the COA is only as good as your ability to confirm it — which is why this registry verifies records with the source before displaying them, and why you should verify any COA you are handed.

What a COA is not

A COA is not FDA approval, not proof a treatment is appropriate for you, and not proof the vial in your hand came from the tested lot. Read what a COA can and cannot prove for the full boundary.