01LC-MS
Molecular identity
LC-MS locks the mass and sequence to the expected molecule.
Release criterion
Analytical protocol · Rev. 4
A run has to earn its box.
We don't rubber-stamp our own chemistry. Independent assays for identity, purity, residual contaminants, physical finish, and documentation are purchased from accredited outside laboratories and written into the report attached to the run number on your vial. A run that misses one of them never gets boxed.
- ≥ 99%
- Minimum purity gate
- 3rd-party
- Every analysis outsourced
- 100%
- Runs traced to a report
Identity & purity
02HPLC-UV
Chromatographic purity
HPLC-UV measured against certified reference material.
Release criterion
03Gravimetric
Net peptide content
Assayed strength weighed against the number on the label.
Release criterion
Contaminants
04Karl Fischer
Residual moisture
Karl Fischer titration straight off the lyophilised cake.
Release criterion
05HS-GC
Residual solvent
Headspace GC hunts for anything the synthesis left behind.
Release criterion
06LAL / USP
Bacterial endotoxin
LAL assay held to USP limits, no exceptions.
Release criterion
07TAMC
Microbial load
Total aerobic count run on finished, capped vials.
Release criterion
08IC
Counter-ion
Acetate and TFA quantified by ion chromatography.
Release criterion
Physical & finish
09Visual
Cake and clarity
Visual integrity, colour, and how cleanly it reconstitutes.
Release criterion
10Torque
Seal integrity
Crimp torque plus authentication of the diffraction label.
Release criterion
11Stability
Accelerated hold
Storage stress to confirm the vial holds its spec.
Release criterion
Documentation
12Signed
Analyst sign-off
A named analyst attached to the file for that run.
Release criterion
Authentication
How to read the seal yourself
The label sits on a diffraction-grating laser substrate. Tip it under a directional lamp and the helix runs through the spectrum while a micro-etched run code surfaces along the bottom edge. That code should pull up the same report as the number printed above it. If the two don't match, the vial didn't come from us.
- 01
Tilt
Angle the vial under a single directional light source.
- 02
Look
The helix should sweep the spectrum, not flash a flat silver.
- 03
Read
Find the micro-etched run code along the lower edge.
- 04
Match
Enter it on the verify page — the report must agree.