Reading a Batch Release Certificate Properly
A release certificate is only useful if you interrogate it. Here is what each field means and what a missing field tells you.
A batch release certificate is the document that connects the vial in your hand to a manufacturing record. It is also trivially easy to fabricate, which is why knowing how to read one matters more than being given one.
The fields that must be present
Batch or lot number. It must match the vial exactly — not approximately, not a similar sequence. This is the primary key of the whole document.
Product name and strength. Should match the label precisely, including the concentration. A certificate for "Dexamethasone injection" attached to a product labelled "Dexamethasone 2 mg/ml" is incomplete.
Manufacture date and expiry date. Both, not one. The interval between them should be consistent with the product's stated shelf life, and a certificate showing a five-year shelf life on an aqueous injectable is not describing a real product.
Assay result. A number, not a word. "Meets specification" without a figure is a claim. "99.4% of label claim" is a result. Most pharmacopoeial specifications for injectables sit in the 95–105% band; a result outside that should not have been released.
Test methods. HPLC assay, sterility, endotoxin, pH, particulate matter — which tests were run, by what method. A certificate listing no methods is describing no testing.
Release signature and date. A named QA release, dated after the test date.
Reading the numbers
An assay of exactly 100.0% on every batch is more suspicious than an assay of 98.7%. Real manufacturing has variance. A supplier whose every certificate reports perfect round numbers is generating documents, not measurements.
Check the internal dates for coherence:
- Testing should follow manufacture, usually by days to weeks
- Release should follow testing
- Expiry should follow manufacture by the product's stated shelf life
Certificates fabricated in bulk frequently get this ordering wrong.
Red flags
- No batch number, or one that does not match the container. Stop here.
- A generic certificate covering multiple batches. Release testing is per batch by definition.
- Assay reported as a claim rather than a value.
- No expiry, or an implausible shelf life.
- A scanned image with no verifiable source, particularly one that has been photographed rather than issued.
- Refusal or delay when you ask for it. A supplier holding genuine stock has the certificate available. A supplier who needs a week to find it is producing one.
The check that matters most
Ask for the certificate for the batch you actually received, after you have received it — not a sample certificate before you order.
Anyone can send you a certificate for a good batch. The question is whether they can send you the certificate for your batch, with the number that is printed on the vial in your hand.
If the two do not match, do not administer the product, and do not accept an explanation that involves the batch numbering being "different in this region".
Our register
We publish the batch register openly, with the assay figure, the manufacture and expiry dates and the QA release for every batch we have shipped. You do not need to ask us for it and you do not need an account to read it.
That is not generosity. It is the only mechanism that lets a buyer verify us rather than trust us, and in this trade trust that cannot be verified is not worth much.
Veterinary use only
For veterinary use in animals only, under the direction of a licensed veterinarian. Not for human consumption. Buyers are responsible for observing the withdrawal periods and medication rules of their racing or competition authority, and for any import requirements in their country.
