Certificate of analysis (CoA): what it is and how to get one

What is a certificate of analysis?

A certificate of analysis is the document that ties test results to a lot of material. It answers three questions for whoever reads it: what was tested, how it was tested and what was found. Manufacturers use CoAs to release batches, buyers use them to accept shipments, and brands publish them so customers can check a product against its label.

FDA uses the term narrowly. Its Small Entity Compliance Guide for the dietary supplement CGMP rule (21 CFR Part 111) uses “certificate of analysis” to mean “a document, provided by the supplier of a component prior to or upon receipt of the component, that documents certain characteristics and attributes of the component.” In everyday use the term also covers reports on finished products, whether they come from a manufacturer’s own quality lab or from an outside lab. “CoA testing” simply means the testing done to produce one.

What should a certificate of analysis contain?

There is no single federal CoA format for every product. For supplier CoAs that a supplement maker relies on, 21 CFR 111.75(a)(2)(ii)(B) sets a floor: the CoA must include a description of the test or examination methods used, the limits of the tests or examinations, and the actual results. A complete report adds the details below.

Elements of a complete certificate of analysis. A supplement maker may rely on a supplier CoA only if it describes the methods, limits and actual results (21 CFR 111.75(a)(2)(ii)(B)); the other rows are common practice.

How is a supplier CoA different from a lab CoA?

A supplier CoA travels with a raw material or bulk shipment and reports the supplier’s own testing of that lot. A lab CoA reports testing you commission on a sample you send. For supplements, Part 111 limits how far a supplier CoA can go: it cannot replace the identity test required for each dietary ingredient unless FDA grants an exemption petition (111.75(a)(1)(ii)), and for other components you may rely on it only after qualifying the supplier and re-confirming its results periodically. The section-by-section rules are on 21 CFR 111 testing requirements.

A certificate of conformance is a third kind of document. It states that a lot meets a specification, usually without listing results. When you need to check a number yourself, ask for the CoA.

How do you get a certificate of analysis for your product?

1. Find out who will read it. Your own release decision, a retailer, a marketplace and a state hemp program may each want different tests. Ask the recipient for its requirements in writing: analytes, limits, reporting basis and any rules about which labs it accepts. Some buyers require CoAs from ISO/IEC 17025-accredited labs, so settle this before you test. Channel-by-channel expectations are summarized in testing requirements by sales channel.
2. Write the specification. List each test with its limit, units and basis. Without one, a CoA reports numbers but cannot give a pass or fail.
3. Match the tests to the product. Starting panels by product type are on the dietary supplement, hemp and CBD and food and beverage pages. Check that each method’s LOQ sits below your limit.
4. Request a quote. We confirm the method, sample amount and price with your quote.
5. Draw the sample from the finished lot. Use sealed units of the packaged lot you will sell, marked with its lot number, and hold back reserve units from the same lot.
6. Submit and ship. Packing and paperwork are covered in how to submit a sample.
7. Review the CoA, then file it. Check the lot number, dates, units and basis against your specification. Supplement makers must keep Part 111 records for 1 year past the shelf life date, if shelf life dating is used, or 2 years beyond the date of distribution of the last batch associated with those records (21 CFR 111.605(a)).

Who can issue a certificate of analysis?

Any party that tests the material can issue one: an ingredient supplier’s quality lab, a contract manufacturer’s lab, or an outside analytical lab hired by the brand. The federal rules for supplements and food do not name a required issuer. Part 111 speaks of the “laboratory facilities that you use” (21 CFR 111.310), and FDA’s food preventive controls rule asks that written product-testing procedures identify the laboratory conducting the testing (21 CFR 117.165(b)(2)(vi)).

What makes a CoA useful is fit: methods, LOQs, lot and reporting basis that match what the reader needs, from an issuer the reader accepts. Retailers, marketplaces and state hemp programs can set their own rules about the lab, which is why step 1 above comes first.

How do brands use a CoA once they have it?

• Batch release. Supplement makers compare results with product specifications before release. Under 21 CFR 111.123(b), quality control personnel must not release a batch that fails any product specification.
• Supplier qualification. Testing an incoming lot yourself and comparing the result with the supplier’s CoA is how a supplier’s certificate earns trust under 21 CFR 111.75(a)(2)(ii)(A).
• Lot-level transparency. A QR code that opens the CoA for the exact lot printed on the package lets a customer check that product, not a sample from an earlier run.
• Trend tracking. Lining up results lot after lot shows drift in potency or contaminants before a result fails.

To work through a report line by line, see how to read a certificate of analysis, which annotates a sample CoA.

Questions about this page

Sources: 21 CFR 111.75, What must you do to determine whether specifications are met? (eCFR) · 21 CFR Part 111, dietary supplement CGMP rule (eCFR) · FDA Small Entity Compliance Guide: CGMP for dietary supplements · 21 CFR 117.165, Verification of implementation and effectiveness (eCFR)
Last reviewed: 3 November 2026