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Testing & documentation

Tested as a filled device, not as a powder.

We could have filled this page with the certificates from our vial catalogue. They are real, they are independent, and they would be completely irrelevant to what you are buying — a different manufacturer, a different product state, and a different set of things that can go wrong. So here is the standard this line is actually held to.

Tested per
Production lot

Identity, purity, sterility, endotoxin and fill volume are run on the filled unit. Documentation for the lot you are shipped comes through the wholesale desk with your order.

Ask the wholesale desk
Why the filled unit

A powder certificate is not a pen certificate.

Plenty of suppliers will hand you a certificate for the raw peptide and let you assume it covers the device. Three things change when the same compound arrives pre-filled, and each one breaks that chain of evidence.

  • Different manufacturer. A certificate follows a batch from one line; it does not follow a compound between facilities.
  • Powder versus solution. Lyophilised peptide under nitrogen is stable for years. The same peptide in solution has a real expiry — which is why pharmaceutical pens are refrigerated and dated.
  • New failure modes. A sealed injector introduces sterility, endotoxin and fill-accuracy questions that do not exist when the buyer reconstitutes the powder themselves.
The panel

What is run, and why each one is on the list.

Every test below is performed on the filled unit — the device you would hand a patient — not on the raw peptide before it goes in.

Identity

Mass spectrometry

Confirms the peptide in the pen is the peptide on the label. The single test no other result means anything without.

Purity

HPLC with chromatogram

Run on the filled solution, not on the powder before filling. A purity figure from before the fill says nothing about what is in the device.

Sterility

USP <71> or equivalent

A pre-filled injector is a sealed sterile presentation. This has no equivalent in a vial line, where the buyer reconstitutes and carries that risk.

Endotoxin

LAL, EU/mL

Bacterial endotoxin survives sterilisation. Reported per millilitre against the dose the device actually delivers.

Fill volume

Gravimetric, per lot

A dose-graduated pen is only accurate if the fill matches the label claim. Verified per lot rather than per unit.

Stability

Timepoint study, in solution

The one that decides shelf life and storage. Peptide in solution degrades where lyophilised powder does not — particularly the GLP-1 class.

Results are reported against a lot number, so any figure you are given can be matched to the carton in your hand. Ask for the lot documentation before you commit shelf space — on this line or anyone else's.

Due diligence

Four questions worth asking any peptide supplier.

Including us. If a supplier cannot answer these about a pre-filled product, that is the answer.

Was this tested on the filled device, or on the powder before filling?
These are different products. A certificate dated before the fill tells you about a raw material, not about what your patient receives.
Is there a sterility and endotoxin result, not just purity?
Purity is the number everyone publishes because it is the cheapest to get. For anything injected from a sealed device it is the least interesting of the three.
What is the shelf life, at what storage temperature, and on what data?
Peptide in solution has a real expiry. If a supplier quotes one without a timepoint study behind it, the number is a guess.
Does the lot number on the certificate match the lot on the carton?
A certificate for a different lot is a marketing document.
Want the full testing protocol? We will send the panel, the methods and the laboratory arrangement in writing. Ask the wholesale desk.