What's on the label is the measured result — net peptide mass, not gross powder weight, plus RP-HPLC purity, on a lot-numbered COA for every batch.
Net peptide mass and RP-HPLC purity — a lot-numbered COA for every batch.
Net peptide mass + HPLC purity, per lot.
PCAC will review 7 peptides for the 503A bulks list, BPC-157, KPV, TB-500, MOTS-c, Emideltide, Semax, Epitalon. Read our briefing →
PCAC will review 7 peptides for the 503A bulks list. Read →
FDA PCAC reviews 7 peptides in July. Read →
Quality & Compliance
Every batch ships with a batch-specific Certificate of Analysis. HPLC chromatograms, mass-spec spectra, stability data, SDS, sequence verification, LAL, and microbial results are available on request.
Vial-filling line · Shanghai facility · captured on production day
Quality You Can Verify
Every shipment ships with the batch's Certificate of Analysis, HPLC purity, mass-spec identity, endotoxin, and microbial limits. Sequence verification and stability data available on request.
≥99%
Purity by HPLC + MS
100%
Batches with COA
<24h
First response
HPLC + Mass Spec on every batch, analytical methods aligned with USP <1225>.
LAL endotoxin + microbial limits for injectable-route applications.
Stability program, accelerated (40°C/75%RH) and long-term data on request.
Analytical Methods
| Test | Method | Target |
|---|---|---|
| HPLC purity | RP-HPLC · USP <621> compliant | ≥ 99.0% |
| Identity (MS) | ESI-MS · ±0.5 Da from theoretical | Confirmed |
| Peptide content | Mass balance + AAA | 75–90% (lyophilized) |
| Water content | Karl Fischer | ≤ 8.0% |
| Counter-ion | Ion chromatography | Acetate (standard) |
| Bacterial endotoxin | LAL (gel-clot / kinetic chromogenic) | < 0.25 EU/mg (injectable) |
| Microbial limits | USP <61>/<62> | Compliant |
| Residual solvents | GC headspace | ICH Q3C limits |
Documentation
We ship a Certificate of Analysis with every order. On request we provide HPLC chromatograms, MS spectra, stability data, SDS, sequence verification, and a full QA workpacket.
Per-batch, includes HPLC purity, identity, water content, microbiology.
Raw chromatogram showing main peak and impurities profile.
ESI-MS confirmation of molecular mass within ±0.5 Da.
Accelerated (40°C/75%RH) and long-term real-time data.
Independently verified amino-acid sequence for peptides > 5 aa.
Full SKU list with vial sizes, MOQ, and lead times. Updated quarterly.
Certifications & alignments
Each item below is backed by a current certificate or alignment assessment held by the PeptideXpo manufacturing facility or its qualified production partners. Certificate numbers, registrar contact, validity periods, and inspection reports are made available under mutual NDA to qualified buyers as part of the standard supplier-qualification packet.
A first reply within 24 hours · Catalog · Sample COA · MOQ · Lead time. Our regulatory and sales teams read every inquiry before any price goes out.
