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PeptideXpo

Quality & Compliance

Transparency, as a product.

Every batch ships with a third-party-verified Certificate of Analysis. Analytical methods are aligned with USP <1225> and ICH Q7.

PeptideXpo vial-filling line in active production — vials moving along the conveyor with operator in cleanroom PPE in the background

Scan vial → Verify COA

peptidexpo.com/coa/PX-26-A0517

Vial-filling line · Shanghai facility · captured on production day

Quality You Can Verify

Scan the vial. See the COA.

Every vial we ship carries a QR code linking directly to that batch's third-party-verified Certificate of Analysis. No tickets, no email loops, no opacity.

≥99%

Purity by HPLC + MS

100%

Batches with COA

<12h

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

What we test on every batch.

TestMethodTarget
HPLC purityRP-HPLC · USP <621> compliant≥ 99.0%
Identity (MS)ESI-MS · ±0.5 Da from theoreticalConfirmed
Peptide contentMass balance + AAA75–90% (lyophilized)
Water contentKarl Fischer≤ 8.0%
Counter-ionIon chromatographyAcetate (standard)
Bacterial endotoxinLAL (gel-clot / kinetic chromogenic)< 0.25 EU/mg (injectable)
Microbial limitsUSP <61>/<62>Compliant
Residual solventsGC headspaceICH Q3C limits

Documentation

Everything your QA team needs.

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.

Certificate of Analysis

Per-batch, includes HPLC purity, identity, water content, microbiology.

HPLC chromatogram

Raw chromatogram showing main peak and impurities profile.

Mass-spec spectrum

ESI-MS confirmation of molecular mass within ±0.5 Da.

Stability data

Accelerated (40°C/75%RH) and long-term real-time data.

Sequence report

Independently verified amino-acid sequence for peptides > 5 aa.

Catalog PDF

Full SKU list with vial sizes, MOQ, and lead times. Updated quarterly.

Certifications & alignments

Built to international standards.

ISO 9001:2015
GMP-Aligned
FDA DMF on File
USP <797> Aligned
EU GMP Annex 1
Third-Party Tested

Let's talk peptides.

First response under 12 hours · Catalog · Sample COA · MOQ · Lead time. Our regulatory and sales teams review every inquiry before pricing.

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