Reference table
Peptide COA and testing standards compared: what each test proves
By Vitality Chems · Published · updated · vendor-authored explanatory note
Short answer
A complete peptide certificate of analysis answers separate questions with separate tests: HPLC for purity, mass spectrometry for identity, quantitation for amount, and a lot number, named lab and lab-hosted lookup for traceability. Endotoxin (USP <85>) and sterility (USP <71>) are separate microbiology tests that a purity or identity result does not cover. The last column counts how many of our 8 published reports include each item, computed from the report data.
Catalog materials discussed on this page
| Test or item | What it proves | Standard or reference | What to look for | Our reports |
|---|---|---|---|---|
| Purity by HPLC (UV) | Share of UV-absorbing material that elutes as the main peak. | Reversed-phase chromatography; method validation per ICH Q2(R2). | Percent value, method, wavelength, and a chromatogram or peak table. | 8 of 8 |
| Identity by mass spectrometry | That the molecule tested has the expected mass. | LC-MS or MALDI; observed mass compared with the theoretical mass (ICH Q6B lists identity among specifications). | Observed and expected mass or m/z values, not just the word 'conforms'. | 3 of 8 |
| Measured quantity per vial | How much material the lab measured in the vial. | Quantitation against a reference standard, usually by HPLC. | A measured value in mg next to the label claim. | 8 of 8 |
| Lot or batch identifier | Which production lot the result belongs to. | 21 CFR 210.3 defines a lot number as a distinctive combination of letters, numbers or symbols that traces a batch. | A lot number that matches the vial label exactly. | 6 of 8 |
| Named laboratory and report date | Who ran the test and when, so the report can be checked. | No single standard; the lab must be identifiable so the report can be confirmed with it. | Lab name, address, report ID and date. | 8 of 8 |
| Confirmable on the lab's own lookup | That the lab itself holds the same report. | Lab-hosted verification page or written confirmation from the lab. | A lookup on the lab's own domain, not a link supplied only inside the PDF. | 4 of 8 |
| ISO/IEC 17025 accreditation covering the test | An accreditation body assessed the lab's competence for that method. | ISO/IEC 17025:2017, with the method listed on the lab's scope of accreditation. | The accreditation certificate number and the method on the published scope. | 0 of 8 (Vanguard is A2LA-accredited, certificate 6377.01, but peptide purity and quantity are not on its scope; Freedom Diagnostics names no 17025 accreditation) |
| Bacterial endotoxins | Endotoxin level in EU per mg. | USP <85> Bacterial Endotoxins Test (LAL methods). | A numeric result in EU/mg and the method (gel-clot, turbidimetric or chromogenic). | 0 of 8 |
| Sterility | Absence of viable microbial growth in the tested sample. | USP <71> Sterility Tests; 21 CFR 610.12. | Method, incubation period and a pass or fail result. | 0 of 8 |
How to use the table
Read each row as a question the certificate should answer. A row that is missing is not a failure of the compound; it means the report does not answer that question, and you should not assume the answer.
Purity and identity are independent. A high HPLC purity number says the main peak dominates; it does not say what the main peak is. Mass spectrometry answers identity.
Accreditation is about scope, not the logo
Accreditation bodies use ISO/IEC 17025 as the criteria for assessing laboratories, and each accreditation lists specific methods on a scope document. A lab can be accredited for some tests and not others, so check that the method on your report appears on the lab's published scope.
We publish this for our own reports: Vanguard Laboratory holds A2LA certificate 6377.01, but peptide purity and quantity are not on its scope, and Freedom Diagnostics names no ISO/IEC 17025 accreditation body.
Microbiology tests are separate
Bacterial endotoxin testing (USP <85>) reports a number in EU per mg. Sterility testing (USP <71>, and 21 CFR 610.12 for licensed biologics) reports growth or no growth after incubation. Neither is implied by an HPLC or mass spec result.
None of our 8 published reports includes endotoxin or sterility results, and we do not claim either.
Related on Vitality Chems
- Verify a lot — open the published report for your vial.
- How to verify a peptide COA — step-by-step lab confirmation.
- Free COA checker — run these checks on any report.
- COA dataset (CSV and JSON) — the data behind the last column.
- Endotoxin testing explained — LAL methods and EU/mg.
- BPC-157 — lab-verified lot report.
- Retatrutide — lots with published HPLC and LC-MS reports.
Frequently asked
What tests should a peptide COA include?
At minimum: HPLC purity with a chromatogram, mass spectrometry identity with observed and expected mass, a measured quantity, a lot number matching the vial, and a named lab with a report ID you can confirm. Endotoxin and sterility are separate tests.
Does HPLC purity prove identity?
No. HPLC purity is the share of UV peak area in the main peak. Identity needs mass spectrometry or another identity method.
Does ISO/IEC 17025 accreditation cover every test a lab runs?
No. Accreditation covers the methods listed on the lab's scope. Check the scope for the method on your report.
Do your reports include endotoxin or sterility testing?
No. None of our 8 published reports includes endotoxin or sterility results.
References
- ICH Q2(R2), Validation of Analytical ProceduresValidation of purity and assay methods.
- ICH Q6B, Specifications for Biotechnological/Biological ProductsIdentity, purity and quantity as specification categories.
- 21 CFR 210.3, Definitions (lot, lot number)Definition of a lot number.
- ISO/IEC 17025:2017, General requirements for the competence of testing and calibration laboratoriesThe standard accreditation bodies assess labs against.
- USP <85> Bacterial Endotoxins (harmonized standard notice)Endotoxin test chapter.
- 21 CFR 610.12, SterilitySterility test requirement for licensed biological products.
