How to Read a Stem Cell COA

A Certificate of Analysis has a specific job: to tie a set of test results to the exact lot in your hand. Here's how to read one section by section.

Start With the Lot Number

Before reading a single test result, check one thing: does the lot number on the COA match the lot number printed on the physical vial? If it doesn't, the document may be a generic specification sheet rather than a result for the product actually in hand. This single check catches more problems than any other line on the page.

Section by Section

• Product ID / lot number — identifies the exact batch. Should match the vial.
• Donor/source and manufacturing information — tissue source, and the facility that manufactured the lot. Look for an FDA facility registration number (FEI), not just a company name.
• Identity / characterization panel — confirms the cells are the type claimed, often via surface marker analysis. This is a different result from a count.
• Viable cell count and viability — the number of live, functional cells present, and the percentage of the total population that's viable — ideally measured post-thaw. See What Is Stem Cell Viability.
• Sterility and safety testing — microbial and, where relevant, endotoxin results. A pass here doesn't substitute for a count or viability result — see Stem Cell Sterility Testing.
• Cryopreservation medium — what the product is stored in, which can matter for handling and thaw protocol.
• Signed approval — a named, credentialed signatory (e.g., a QC manager or scientific director) taking responsibility for the release decision, with a release date.

A Quick Way to Stress-Test Any COA

This page is educational reference material for licensed healthcare providers and does not constitute medical, legal, or regulatory advice. HCT/P products are not FDA-approved.