The report
The certificate is the product. Everything else is logistics. This page states in advance what will be on it, so that nothing on the document has to be interpreted generously.
| Section 1 | Identification and verification |
| Section 2 | Specimen as received |
| Section 3 | Results, one row per determination |
| Section 4 | Determination detail, one section per method |
| Section 5 | Scope, exclusions and signature |
Every determination occupies one row and carries four fields: what was determined, the method it was run under, the result with its unit, and the specification it is assessed against. A row missing any of them is not issued.
| Determination | Method | Result | Specification |
|---|---|---|---|
| Identity | LC-MS, ICH Q2(R2) | theoretical and measured mass, Δ in Da | acceptance window stated |
| Purity | RP-HPLC-UV 214 nm | area normalisation, % | acceptance criterion stated |
| Net peptide content | Combustion elemental analysis | mass fraction, % and mg | declared content |
| Endotoxins | Kinetic chromogenic, USP <85> / <86> | EU per vial, with spike recovery | product limit |
| Microbial enumeration | USP <61>, TAMC and TYMC | counts in CFU/g, not pass/fail | USP <1111> criteria |
| Elemental impurities | ICP-MS, USP <232> / <233> | µg/g per element | ICH Q3D limits |
The figures below illustrate format. They are not results.
Written this way
"Microbial enumeration, USP <61>, TAMC 40 CFU/g, TYMC <10 CFU/g."
"Identity by LC-MS. Theoretical 1419.5 Da, measured 1419.4 Da, Δ 0.1 Da."
"Peptide purity by RP-HPLC-UV at 214 nm, area normalisation, 98.2 %. Net peptide content 78.4 %, equivalent to 7.84 mg per labelled 10 mg vial."
"Lead by ICP-MS: 0.08 µg/g against a limit of 0.5 µg/g."
Never this way
"Sterility: pass" where the test performed was TAMC and TYMC.
"Identity confirmed" with no mass, no standard and no difference stated.
"Purity 98.2 %" presented on its own, as though it answered how much peptide is in the vial.
"Heavy metals: not detected" with no detection limit, which is a statement about the instrument rather than the sample.
Section 2 records the specimen as it arrived: declared name, manufacturer or supplier, batch number, expiry, dosage form, declared quantity, seal condition, appearance of the lyophilisate, and a photograph taken before the container is opened. That photograph is part of the record. A dispute about what was actually submitted is otherwise unresolvable.
Section 5 lists what was not determined. This is deliberate and it is the part most certificates omit. A client reading a purity figure needs to see, on the same page, that endotoxins were not measured — otherwise the absence reads as an absence of problems.
The certificate describes the specimen submitted. Where sampling was representative it supports a statement about the batch. It supports no statement about any other batch, and it is not an approval, an endorsement, a marketing authorisation or a safety assessment of the substance itself.
| Raw data | Chromatograms, spectra and instrument files supplied on request |
| Retained sample | Held so a disputed result can be re-examined |
| Chain of custody | Recorded from receipt to disposal |
| Publication | Client's decision; nothing is published by default |
Each certificate carries a report number and a unique key. Verification resolves against ANALYTON, not against a supplier's website, which is the only arrangement under which a fabricated document fails the check.
Verification proves the document is genuine and unaltered. It does not prove that the unit in your hand belongs to the batch named on it. Any laboratory implying otherwise is overstating what a certificate can do. If the batch number on the vial does not match the batch number on the certificate, the certificate is about a different product.