Analytical release: how every lot is qualified
Most suppliers test a sample and extrapolate. BioRePep qualifies every lot at an independent laboratory against release criteria we publish, holds the lot until it meets them, and issues a certificate of analysis tied to the lot number on your label.
Sourcing
Peptide API is sourced from audited synthesis partners with documented batch records, sequence verification and residual-solvent data for each lot.
Identity
LC-MS or MALDI-TOF confirms the observed molecular mass against the theoretical mass of the target sequence before any further release testing.
Purity and content
RP-HPLC at 214 nm quantifies purity; amino-acid analysis confirms net peptide content. Single peptides below 99.0% are rejected, not discounted.
Safety panel
LAL kinetic endotoxin, USP <71> sterility (injectable format), USP <61>/<62> microbial limits (oral, nasal, topical) and ICP-MS heavy metals, run by an independent laboratory.
Release
A certificate of analysis is issued per lot, tied to the lot number printed on your label, and the product is released to cold-chain storage. Only then does it ship.
Release specifications on the certificate of analysis
| Test | Method | Release criterion |
|---|---|---|
| Identity | LC–MS / MALDI-TOF | Observed mass within ±0.1% of theoretical |
| Purity | RP-HPLC, 214 nm | ≥ 99.0% (single peptides); each component quantified in blends |
| Peptide content | Amino acid analysis / UV | Within ±10% of label claim |
| Endotoxin | LAL kinetic chromogenic | < 1.0 EU per vial (injectable-format vials) |
| Sterility | USP <71> membrane filtration | No growth at 14 days (injectable-format vials) |
| Microbial limits | USP <61> / <62> | Within limits; absence of specified organisms (oral, nasal, topical) |
| Heavy metals | ICP-MS | Pb, As, Cd, Hg below USP <232> limits |
| Residual solvents | GC headspace | TFA and acetonitrile within USP <467> limits |
| Water content | Karl Fischer | ≤ 5% (lyophilized vials) |
Request a certificate of analysis
Tell us the product and the lot number printed on your label. We'll send the matching COA the same business day.