Accepted answer
A useful certificate has five elements: the lot number, the analytical method, the reported result with units, the date of analysis, and the primary data or a reference to it.
Writing the lot number on your vial in permanent marker is worth doing because it later proves that the certificate traces to your material.
What each test answers
| Test | Answers | Does NOT answer |
|---|
| RP-HPLC, area % | What fraction of detected material is the target | How much target is present |
| Quantified content | Milligrams of peptide per vial | What the impurities are |
| ESI-MS identity | Whether the molecular weight matches | Purity, or isomeric substitution |
| Peptide mapping | Sequence, localised to a fragment | Quantity |
| Karl Fischer | Water content of the solid | Solvent content |
| LAL endotoxin | Pyrogen load in EU/mg | Sterility |
| Sterility test | Growth in defined media over 14 days | Endotoxin, or bioburden count |
Concretely, the certificate is a snapshot and nothing else — it tells you about the material on one day from one sample of one lot, and extrapolation beyond that requires logic.
Pharmacopoeial standards require method validation steps that research-grade certificates almost never claim to meet, and the absence of that claim is itself information.
One qualification: a single result from a single vial at a single time is a point estimate with no error bar, and no amount of decimal places changes that.
My working rule is that a document without a lot number, a method section and a test date is marketing.
The placebo-arm figure is the part everyone omits. – rhian_prydderch 41 days ago add a comment