Identity
Is the material actually the named substance? A purity percentage does not answer identity by itself.
Product Risk Desk
What a peptide COA can—and cannot—tell you
A certificate of analysis is a report about stated tests on a stated sample or lot. It is not FDA approval, and by itself it does not prove that the vial in someone’s hand is correctly identified, potent, sterile, endotoxin-free, stable, or the same material that was tested.
Eight separate questions
Assay or potency
How much active ingredient was measured? This is a different question from purity.
Purity and impurities
What proportion of the tested material produced the expected analytical signal, and what other peaks or contaminants were detected?
Sterility
Did a validated test find viable microorganisms in the tested sample? Chemical purity is not a sterility test.
Bacterial endotoxins
Did the tested sample meet a stated endotoxin limit? A sterile result does not answer this separate question.
Particulates
Was the injectable checked for visible and subvisible particles?
Stability
Does evidence support the stated storage conditions and expiration or beyond-use date? A single snapshot does not establish shelf life.
Sample and lot match
Is there a trustworthy chain connecting the report, tested sample, labeled lot, and finished vial? A genuine report can still be irrelevant to a different sample.
Red flags that deserve another question
- No laboratory name, method, test date, sample identifier, or lot identifier
- A single “purity” number presented as proof of sterility, potency, and identity
- The report covers raw powder while the claim is about a finished injectable
- The seller selected and submitted the sample but provides no chain-of-custody information
- A “research use only” label is presented as proof that human-use marketing is lawful
What this guide will not do
It will not authenticate a seller, recommend a laboratory, certify a vial, or turn incomplete paperwork into a purchase recommendation. FDA’s records show why identity, strength, purity, sterility, endotoxins, and particulates are separate quality questions.