Quality protocol
Every batch, 8× tested.
Independent laboratories, not in-house rubber stamps. If a lot fails any single assay it does not ship, and we do not re-test until a favourable number appears.
Purity — HPLC-UV
Reverse-phase HPLC with UV detection quantifies the main peak against a certified reference standard. Release threshold: ≥ 98%.
Content verification
Net peptide content is measured so labeled mass reflects actual peptide, not counter-ions or residual solvent.
Identity — mass spectrometry
ESI-MS confirms observed molecular weight against the theoretical weight of the sequence.
Heavy metals — ICP-MS
Lead, arsenic, cadmium and mercury screened against USP <232> elemental impurity limits.
Sterility — USP <71>
Membrane filtration sterility testing on the filled, sealed vial.
Endotoxin — LAL
Kinetic chromogenic LAL assay. Release threshold: < 0.5 EU/mg.
Batch conformity
An independent reviewer confirms the released lot matches its specification sheet in full before it ships.
Fentanyl screen — LC-MS/MS
Targeted screen confirming absence of fentanyl and known fentanyl analogs.
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