Our standards
Anyone can print a purity figure on a label.
What matters is who measured it, whether they knew whose product it was, and whether you can read the chromatogram yourself. Here is exactly how our material reaches you.
Five stages, no shortcuts.
The sequence below is fixed. There is no expedited path through it, including for our own back-orders.
Synthesis and sourcing
We commission synthesis from a short list of contract manufacturers audited on site. Each partner works to a written specification that fixes resin chemistry, purification stages, and the counter-ion we will accept. We do not buy on the spot market, and we do not accept a lot without its synthesis record.
Incoming quarantine
Material arrives into physical quarantine and is not released to fill until testing clears it. Quarantined lots are held at −20 °C under continuous logging. Anything that arrives outside its temperature envelope is rejected without re-test.
Two independent assays
Every lot is assayed twice, by two laboratories with no commercial relationship to each other and no knowledge of the other's result. Identity is confirmed by mass spectrometry, purity by reverse-phase HPLC at two wavelengths. Where the two results disagree beyond tolerance, the lot is rejected — we do not average them and we do not re-test to a pass.
Fill and lyophilisation
Sterile-filtered at 0.22 µm and filled under laminar flow in a certified ISO Class 7 environment, then lyophilised and sealed under inert headspace with a crimped cap. Fill weights are verified gravimetrically across the run, not just at the start.
Documentation
The finished lot is documented as a packet: identity, purity with chromatograms, the full impurity profile above 0.1%, water content by Karl Fischer, endotoxin by LAL, and peptide content net of counter-ion. The packet is attached to the lot number, so what you read is what is in the vial you receive.
The list that costs us money.
- Re-test a failed lot until it passes.
- Publish a specification range in place of a measured result.
- Ship a lot whose retention sample we have not kept.
- Answer a question about dosing, protocols, or human use.
- Fill an order we believe is intended for a person.
Where the material comes from.
We commission from three audited synthesis partners across two countries and rotate assay laboratories quarterly so no single relationship can quietly drift.
Audit summaries and the current assay-lab pairing are available to institutional accounts on request. We do not publish partner names, because exclusivity is what lets us hold specifications that a spot buyer cannot.