How we verify.
No lot leaves the facility unverified. Every batch is characterised by two orthogonal analytical methods — one for purity, one for identity — under ISO/IEC 17025 accredited methodology.
High-Performance Liquid Chromatography.
For chromatographic purity verification at thresholds exceeding 99%.
Reverse-phase HPLC separates peptide components by their hydrophobic interaction with a C18 stationary phase. A linear gradient of acetonitrile in 0.1% trifluoroacetic acid carries each species through the column at a characteristic retention time, producing a chromatogram from which purity is quantified by area-percent integration of the principal peak relative to all detected species.
Mass Spectrometry.
For molecular identity confirmation at parts-per-million mass accuracy.
Each peptide is ionised under electrospray and resolved on an Orbitrap-class mass analyser. The observed monoisotopic mass is compared against the theoretical value computed from the peptide's amino-acid sequence; agreement within ± 5 ppm constitutes confirmation of molecular identity.
Isotopic envelope analysis simultaneously confirms charge state and resolves any co-eluting isobaric species, providing orthogonal verification to the chromatographic separation.
The release workflow.
- 01
Synthesis Completion
Cleavage from resin, lyophilisation, and packaging into individually labelled vials.
- 02
Sample Withdrawal
A representative sample is withdrawn from each lot under cleanroom conditions.
- 03
HPLC Purity Analysis
Chromatographic separation and area-percent quantification against an internal standard.
- 04
Mass Spectrometric ID
Monoisotopic mass measurement and isotope envelope confirmation.
- 05
Dossier Compilation
Lot-specific Certificate of Analysis generated, signed, and archived to LIMS.
- 06
Release & Shipment
Approved lots cleared for distribution; rejected lots quarantined for root-cause investigation.
COA Library access.
Every lot we have ever released, with its certificate of analysis, indexed by product category.