Quality and testing
What "US-manufactured, ≥99% purity" means in practice, and the paperwork you get to prove it.
Manufacturing
Peptides are synthesized by solid-phase synthesis in US facilities operating under cGMP-aligned quality systems, purified by preparative HPLC, and lyophilized under nitrogen. Injectable-grade vials are filled in ISO-classified cleanrooms and crimp-sealed with tamper-evident caps. We do not relabel imported finished vials.
Release testing, every lot
- Purity by analytical HPLC, specification ≥ 99.0%
- Identity by LC-MS against theoretical mass
- Net peptide content and water content (Karl Fischer) on bulk API
- Bacterial endotoxin (LAL) and sterility (USP <71>) on injectable-grade vials
- Residual solvents and counter-ion (TFA/acetate) where applicable
Third-party confirmation testing is run on a rotating basis and available on request for any lot.
Documentation shipped with every order
- Lot-specific certificate of analysis
- Pedigree / transaction statement and chain-of-custody record
- Safety data sheet and storage instructions
- Supplier qualification packet (on account setup, refreshed annually)
Storage, shipping and traceability
- Lyophilized product held at −20 °C; shipped 2–8 °C with temperature indicator
- Retained samples held 24 months per lot
- Written recall and lot-trace SOP; complaints logged and investigated with a written response