01
Synthesis
SPPS under contract with audited partner facilities; every batch tied to a raw-material genealogy.
Fmoc / SPPS
02
Cleavage & purification
Preparative RP-HPLC to a target ≥99% single-peak fraction, pooled and re-analyzed.
Prep RP-HPLC
03
Identity
ESI-MS confirmation against calculated monoisotopic mass, ±0.1 Da tolerance.
ESI-MS
04
Independent re-test
A blind aliquot goes to a second accredited lab. Disagreement quarantines the lot.
Third party
05
Fill & lyophilize
Class 7 fill, nitrogen headspace, crimp seal, then 100% visual and weight check.
ISO 7 fill
06
Release & ship
QA signature binds the COA to the lot code; cold-chain packout with temperature strip.
2–8 °C