Accepted answer
In practice, ask whether the certificate answers the question you are actually asking, because the answer is often no.
Batch versus lot is a semantic distinction that determines whether one certificate applies to ten vials or to one, and checking this distinction is worth a minute.
Reconciling gross mass to label claim
| Component | Typical share | Counted in purity? | Counted in content? |
|---|
| Target peptide | 88–94 % | Yes, as main peak | Yes |
| Related impurities | 1–3 % | Yes, as other peaks | No |
| Counter-ion (TFA or acetate) | 2–8 % | No | No |
| Residual water | 2–6 % | No | No |
| Bulking agent, if present | 0–40 % | No | No |
Concretely, comparison across certificates from different laboratories is almost never valid, even when the material is the same, because the methods are almost never the same.
Industry guidance on this topic is consistent because it comes from first principles rather than convention.
My working rule is that a document without a lot number, a method section and a test date is marketing.
edited 11 Nov 2024 by tobias_maartens — added a caveat about sampling
8I would add a sentence about sterility here, since it is the thing people skip. – forty_two_c 4 months ago The placebo-arm figure is the part everyone omits. – Dr_Tomas_Kral 5 months ago add a comment