A quality system built like pharmaceutical release
Every lot must clear the full specification — sourcing, purification, identity, stability and documentation — before it is allowed into a vial.
cGMP sourcing
Peptide substance is manufactured by cGMP-certified partners under audited master files; every incoming drum is identity-tested before it enters inventory.
Preparative purification
Crude peptide is purified by preparative reverse-phase HPLC, then lyophilized under sterile, classified conditions into nitrogen-flushed amber vials.
Full release testing
Purity, identity, water, counter-ion, heavy metals and endotoxins are tested on the actual lot — not on a reference batch from the same process.
Stability program
Real-time and accelerated stability pulls back the 24-month shelf life claimed on the label; excursions are investigated, not shrugging off.
Documented release
Each lot gets a signed certificate of analysis with raw chromatograms, issued against the batch number that appears on your vial.
Traceable genealogy
Batch records link raw material drums, process steps, test results and retained samples — one identifier follows the material end to end.
Release specification
A lot is only released when every row passes. There is no “purity-only” release: a vial that is 99.5% pure but fails identity or endotoxins never ships.
| Test | Method | Acceptance criteria |
|---|---|---|
| Purity / assay | Gradient RP-HPLC (UV 214 nm) | ≥ 99.0% area |
| Identity | ESI mass spectrometry | Conforms to theoretical mass |
| Water content | Karl Fischer titration | Within specification for format |
| Counter-ion | Ion chromatography | Within specification for format |
| Heavy metals | ICP-MS | < 10 ppm total |
| Endotoxins | Kinetic LAL | < 0.05 EU/mg |
| Appearance | Visual inspection | White to off-white lyophilized cake, intact seal |
Stability & storage
Sealed vials are stored at −20 °C and supported by a stability program covering the full 24-month shelf life — periodic pulls test purity, water content and appearance against the release baseline. Lyophilized peptide is deliberately the supplied form: it is far more stable than solution, and researchers control reconstitution timing in their own lab.
Once reconstituted, keep vials at 2–8 °C and use within 30 days; avoid freeze–thaw cycles. Storage guidance ships on every label and product page.
Independent verification & documents
Internal release testing is only half the story — every lot is also blind-coded and split to an outside ISO 17025 lab. See third-party testing for the panel and workflow, and the batch register for the certificates themselves. Order-level questions go through contact the lab.