What a certificate of analysis should show

A certificate of analysis (COA) is a document that reports the results of tests on a specific lot of material. A useful one identifies the material and the lot, lists each test with its method, acceptance limit and actual result, names the laboratory that did the work, and is dated and signed. It describes the sample that was tested. It does not describe any use of the material, and it does not settle whether a product can be sold to a particular buyer.

For a research supplier, the COA is often the most technical document a buyer sees. Presenting it accurately, and being clear about what it covers, matters more than how polished it looks.

A published reference point

Formats vary between laboratories, and which requirements apply to your products is a question for a qualified lawyer. One published reference is FDA's guidance on good manufacturing practice for active pharmaceutical ingredients, known as Q7. Its section on certificates of analysis recommends that a certificate include the name of the material, its grade where appropriate, the batch number and the date of release; that it list each test performed, with the acceptance limits and the numerical results obtained; and that it be dated and signed by authorized quality personnel and show the name, address and telephone number of the original manufacturer.

That guidance was written for a specific regulated setting, and citing it does not mean your products fall under it. It is useful here as a plain description of what a complete certificate records.

The parts of a COA

Material identity

The material's formal name and any identifiers you use on the product page, such as catalog number, CAS number where one exists, formula or sequence. The name on the certificate should match the name on the label and the page.

Lot or batch number

The lot number links the certificate to physical stock. It should match the number printed on the container the buyer receives. A certificate without a lot number cannot be tied to anything in particular.

Dates

The test date and the issue or release date. If you assign a retest or expiry date, Q7 recommends showing it on the label and, depending on the type of date, on the certificate as well. Dates let a reader see whether the certificate is current for the stock being sold.

Tests, methods and acceptance limits

Each test performed, the method used, and the specification the result was measured against. Common examples for research materials include identity testing, purity by a stated chromatography method and mass confirmation. A purity result means little unless the reader can see how it was measured and what limit it had to meet.

Results

The actual result for each test, as a number where the test produces one. A line that says only "pass" or "conforms" is less informative than a figure next to its limit.

Laboratory and sign-off

The name, address and contact details of the laboratory that performed the analysis, and the signature or authorization of the person who released the results. Q7 also notes that when a certificate is reissued by a repacker, agent or broker, it should name the laboratory that did the analysis and refer to the original manufacturer and the original batch certificate, with a copy attached.

Presenting a COA honestly

How you show a certificate on your store is a claim in itself. The FTC's policy statement on advertising substantiation says advertisers need a reasonable basis for objective claims before they make them, and a claim such as "tests prove" needs at least the support it advertises. If your page says every lot is independently tested, that should be true for every lot.

• Match the lot. Show the certificate for the lot you are currently shipping, or let buyers look up the certificate by the lot number on their container.
• Do not reuse certificates. A certificate for one lot, one product or one supplier does not apply to another, even if the material is the same.
• Do not edit results. If a figure needs correcting, ask the laboratory for a corrected certificate. Do not change numbers, dates or names yourself.
• Say who tested it. If the testing was done in-house, say so. If an outside laboratory did it, name it, and keep their original report.
• Keep redactions minimal and explained. If you hide supplier details for commercial reasons, say that you have done so and keep the original on file.
• Keep the page and the certificate in step. The purity figure, form and quantity on the product page should match the certificate. See writing accurate product descriptions for research compounds.
• Archive old certificates. Keep every certificate you have published, with the dates it was live, so you can show what a buyer saw at the time of an order.

What a COA does not prove

A certificate has a narrow job. Being clear about its limits avoids overstating it to buyers or reviewers.

• It covers the sample tested. Results apply to the sample the laboratory analyzed, at the time it was analyzed. Storage, handling and shipping after that are outside the certificate.
• It does not cover tests that were not run. A purity result says nothing about properties the laboratory did not test for.
• It does not establish intended use. A certificate describes a material's properties. Intended use is judged from labeling, marketing and the circumstances of sale. See intended use, and why a label is not enough.
• It does not make any use appropriate. A certificate is not evidence that a material is suitable for people or animals, and should never be presented that way.
• It is not an approval. A COA is not a regulatory clearance, and it is not a signal of how a payment processor will view your business. Stripe and the card networks make their own decisions.

How this fits with the rest of a compliance program

Certificates are one piece of the documentation around an order, next to your product pages, labels, terms and buyer records. Link each product page to its current certificate, keep the archive, and check the two against each other whenever a lot changes. A research-use-only product page checklist covers the rest of the page.

When a reviewer or a buyer asks what was shown at the time of an order, it helps to have the order records in one place. Claddr stores buyer checks, signatures, holds and payments against each order in a tamper-evident record. See how Claddr's audit record works.