Quality
What a certificate covers
Every lot is released on a laboratory certificate for a sample drawn from that lot (release program v1). Here is what that certificate reports, what it does not, and what is next.
| On this CoA | Not on this CoA | Next |
|---|---|---|
| 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. | Identity (LC-MS)Not part of the release panel. A lot page lists it only when that lot's certificate reports it. | Lot-by-lot certificates, starting with the next receipt |
| 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. | EndotoxinNot part of the release panel. A lot page lists it only when that lot's certificate reports it. | Endotoxin and heavy metals on lots released after [MONTH YEAR] |
| 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. | Heavy metalsNot part of the release panel. A lot page lists it only when that lot's certificate reports it. | |
| The lot, the laboratory and the test dateThe certificate describes a sample drawn from that lot; the lot page links to it. | SterilityNot part of the release panel. A lot page lists it only when that lot's certificate reports it. | |
| Results for individual vialsThe laboratory tests a sample drawn from the lot, not each vial. | ||
| Suitability for any useA certificate reports what the laboratory measured. It says nothing about use in people or animals. |
On this CoA
- 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.
- 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.
- 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.
- The lot, the laboratory and the test dateThe certificate describes a sample drawn from that lot; the lot page links to it.
Not on this CoA
- Identity (LC-MS)Not part of the release panel. A lot page lists it only when that lot's certificate reports it.
- EndotoxinNot part of the release panel. A lot page lists it only when that lot's certificate reports it.
- Heavy metalsNot part of the release panel. A lot page lists it only when that lot's certificate reports it.
- SterilityNot part of the release panel. A lot page lists it only when that lot's certificate reports it.
- Results for individual vialsThe laboratory tests a sample drawn from the lot, not each vial.
- Suitability for any useA certificate reports what the laboratory measured. It says nothing about use in people or animals.
Next
- Lot-by-lot certificates, starting with the next receipt
- Endotoxin and heavy metals on lots released after [MONTH YEAR]
Each lot page shows the certificate as the laboratory issued it, the results against their limits, and the laboratory's own verification link where one exists. Look up a lot or read how a lot is tested and released.
Need a fill or compound we do not stock? Request it here.
How to check a certificate of analysis, ours or anyone's
Seven questions to ask of any certificate before relying on it, and what our lot pages show for each.
1.Is the laboratory named, and can you reach it?
A certificate without a named laboratory cannot be checked. Find the laboratory's own website; some laboratories let anyone confirm a report there from its number or code.
On our lot pages: The laboratory that analysed the sample is named, with the laboratory's own verification link where the laboratory offers one.
2.Is the accreditation real, and does it cover the method?
ISO/IEC 17025 is the general standard for the competence of testing laboratories. Accreditation bodies such as A2LA and ANAB publish searchable directories: look up the certificate number and check that its scope covers the method used, such as HPLC. A clinical certification (CLIA) concerns testing of human specimens, not the chemical analysis of a material.
On our lot pages: A laboratory's accreditation is shown only after we have checked it against the accreditation body's own record: the standard, the body, the certificate number, a link to its scope and the date we checked. Nothing is shown otherwise.
3.Does the certificate describe the lot you have?
A certificate describes the sample that was analysed and nothing else. Its lot or batch reference should match the lot of the material in front of you; a certificate for another lot, or for a product in general, says nothing about yours.
On our lot pages: Each certificate belongs to one lot. Your packing slip names the lot of every line, with a QR code to that lot's page, and your order page links each line to its lot.
4.When was the sample analysed?
Check the analysis date. A recent date on an old document, or no date at all, is a reason to ask questions.
On our lot pages: The analysis date is shown beside the laboratory's name.
5.Do the methods answer the right questions?
HPLC purity is the share of the main peak among the peaks detected; on its own it does not establish what the main peak is. Identity needs comparison with a reference standard or a method such as mass spectrometry, and measured content (in mg) compares the amount found with the amount declared.
On our lot pages: The results are listed test by test against their limits, each with a short note on what the test does and does not show.
6.Is it the original document?
A PDF is easy to edit. Prefer the copy the laboratory itself hosts or confirms, and compare files with a checksum when you can.
On our lot pages: Our archived copy of the laboratory's PDF is unchanged, with its SHA-256 hash to compare a downloaded copy against. Where the laboratory hosts its own copy, the lot page links it and says whether we have compared the two byte for byte.
7.Is it the lot that is actually being shipped?
A certificate on a product page can belong to an earlier lot. Ask which lot ships, and check that the certificate names it.
On our lot pages: The product page names the lot that orders ship from, the lot page says "Currently shipping" only while orders actually ship from that lot, and a lot that failed its tests is never sold.
For laboratory research use only. Not for human or veterinary use or consumption. Not for diagnostic use. Not evaluated by the U.S. FDA.