05
Content is an amount.
mg of peptide in the vial, against a reference standard, with its uncertainty and its basis.
01
The report itself.
ID, version and page count on every page. Dates in order: received, tested, issued.
02
The sample, as received.
What the lab received, in its own photo. Anything the client supplied is marked.
03
Identity, by mass.
Similar peptides can leave the column together. Their masses differ: look for the error in ppm.
04
Purity is a share.
The main peak’s share of all peaks, at one wavelength. Not water, salts, microbes or endotoxin.
06
Safety tests.
Each answers its own question and needs its own sample.
- Endotoxin (LAL)
- Bacterial debris that causes fever. It is there even when no bacteria live.
- EU per vial · EU per mg
- LOQ · spike recovery
- Sterility (USP <71>, 14 days)
- Do live microbes grow from the sample?
- growth · no growth
- units tested · controls
- Heavy metals (ICP-MS)
- Elements left from manufacturing.
- µg per vial
- LOQ · spike recovery
A faster microbial screen or a bioburden count is not a sterility test.
07
A pass needs a rule.
A verdict needs a stated specification and a decision rule. Near a limit, the uncertainty decides.
08
Sign-off.
Who ran the tests, who checked the raw data, who released the report.
09
Check it at the source.
Open it on the lab’s own website. Compare the numbers, the status and the fingerprint.
Warning signs.
On any COA, from any lab.
- 01 Identity from retention time alone.
- 02 Purity with many decimals and no uncertainty.
- 03 mg with no basis and no reference standard.
- 04 “Pass” with no specification.
- 05 A test date before the receipt date.
- 06 A sterility result sooner than 14 days after receipt.
- 07 No way to check the report on the lab’s own website.
- 08 One report for many products or sellers.