Everything you need to know
Before a clinic or practice relies on a supplier's peptide certificate, the report should name the sample, state the identity and purity methods, and include content in mg whenever the label states a strength. A purity-only PDF is usually not enough.
What should a peptide COA include before a clinic relies on it?
Seven things: sample identifiers, a named identity method, purity with its wavelength, content in mg, endotoxin and sterility where your policy calls for them, and a way to verify the document. Purchasing and quality reviewers care about acceptance and defensibility. A checklist makes the review the same every time, whoever does it.
What is the minimum analytical checklist?
One: sample identifiers, meaning the source, the lot or batch number, the claimed peptide and strength, and the date the laboratory received it. Two: the identity method, because retention time alone, co-injection and mass are different strengths of evidence. Three: purity by reverse-phase HPLC with the detection wavelength named. Four: content in mg per vial against a characterised reference standard, whenever the label states milligrams. Five: endotoxin by USP <85>, with the limit applied, where your acceptance policy calls for it. Six: sterility by USP <71>, a 14-day test, where your policy calls for it. Seven: verifiability, meaning you can confirm the certificate with the issuing laboratory and not only from a forwarded PDF.
Which gaps should stop a purchase?
Purity with no content figure when the label states mg. No identity method named. A certificate for a different lot than the shipment. "Third-party tested" with no laboratory name or report number. Endotoxin or sterility claimed with no method reference. What a batch number does and does not prove.
Is a purity-only certificate enough?
Usually not. Purity does not confirm the milligrams on the label, and it says nothing about endotoxin or sterility. More on purity versus content.
How does the checklist map to Prodigy Labs packages?
Basic ($195) does not include content. Tier 1 Confirmed + Content ($295) is the first published package that answers the milligram claim. Tier 2 Injectable Safety Panel ($750) adds endotoxin, heavy metals and bioburden. Tier 3 ($1,195) adds the 14-day USP <71> sterility test and mass confirmation. See what each package includes.
What does a laboratory certificate not do?
It does not approve a product, release a batch or tell anyone how a material may be used. Prodigy Scientific performs contract analytical testing; we do not compound, manufacture or release drug products. This checklist is about analytical documentation for purchasing and quality review. It is not medical, legal or compounding advice.