Quality
How we test and release lots
A lot is sold only after a laboratory certificate for a sample drawn from it has been reviewed against our release program and a person in Quality has released it. Each lot's page shows its own results.
From registration to release
01
Lot registered
Each manufacturing lot gets its public lot ID before anything ships. The supplier's own lot number stays private.
02
Labeled sample to the laboratory
The sealed sample vials the laboratory asks for go to an analytical laboratory under our client order: either the supplier ships them directly, or we send them from units of the lot we have received. Each submission records which, and the lot page states it once confirmed.
03
Certificate and review
The laboratory reports its results to us. Quality reviews the certificate against the release program below; a certificate outside any limit cannot support a release.
04
Release and publication
A person in Quality releases the lot. The certificate PDF is archived unchanged, its SHA-256 is recorded, and the lot page publishes the laboratory, the results, the archived PDF, the hash and the laboratory's verification link where one exists.
05
Received at our warehouse
Units of the released lot, carrying the same label version as the tested sample, are received at our own warehouse in the United States. They are checked against the approved label and photographed before they can be sold.
06
After release
Later certificates for the same lot are published as retests. A retest outside a limit puts the lot on hold for review; a recall is announced on the lot page.
Release panel
The tests a certificate must report, and the limits it must meet, for the certificate to back a lot's release (release program v1). These are acceptance limits, not a description of any particular lot. Each lot page shows the method exactly as the laboratory printed it.
| Test | What it looks at | Release limit |
|---|---|---|
| Identity (HPLC retention time) | The laboratory runs the sample and a reference standard on the same HPLC system and compares the time at which the main peak appears. Conforms means the two times match. | Conforms to the reference |
| Purity (HPLC) | The share of the main compound among everything the HPLC detector sees in the sample, expressed as the main peak's area relative to all detected peaks. | Minimum set by Quality; each lot page shows the measured result |
| Measured content (HPLC) | How much of the compound the tested vial contained, measured by HPLC against a reference standard and reported in milligrams, next to the strength declared on the label. | Within the declared strength; tolerance being confirmed with the laboratory |
Also reported on the lot page when a certificate includes them, and not required for release under the current program: Identity (LC-MS), Endotoxin, Heavy metals, Sterility. What a certificate covers, what it does not, and what is next.
Before a release, the lot also needs its approved label version on the tested sample vials and the archived certificate PDF with its SHA-256. Units received at our warehouse sell only after the label on them is checked and an intake photo is on file.
What a certificate covers
A certificate describes a sample drawn from the lot and tested by the laboratory. Each lot page states this scope in the same words, filled in with that lot's details:
A sample drawn from lot [lot ID] was tested by [laboratory] on [test date] (accession [accession number]). Results describe the tested sample as representative of the lot. Individual vials were not individually tested.
Lot statuses
- Lot status: Testing
- This lot is being tested. It is not for sale until its results are reviewed and it is released.
- Lot status: Released
- This lot was released after its certificate of analysis was reviewed.
- Lot status: On hold
- This lot is on hold pending a quality review. It is not for sale while on hold.
- Lot status: Rejected
- This lot did not pass review and was never sold.
- Lot status: Recalled
- This lot was recalled. Do not use material from this lot.
Check a lot
Enter the lot ID from your packing slip, or read the FAQ for more on lots and certificates.
For laboratory research use only. Not for human or veterinary use or consumption. Not for diagnostic use. Not evaluated by the U.S. FDA.