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.
Released-batch vials · Shanghai facility · post-QA hold
Quality You Can Verify
Every batch ships documented.
Every Vialdyne shipment ships with the batch's Certificate of Analysis — HPLC purity, mass-spec identity, LAL endotoxin, water content, residual solvents, and microbial limits. Sequence verification and ICH stability data available on request.
≥99%
Purity by HPLC
100%
Per-batch COA
<12h
Doc response
HPLC + Mass Spec on every batch, analytical methods aligned with USP <1225>.
LAL endotoxin + microbial limits for sterile compounding-pharmacy use.
ICH Q1A stability, accelerated (40°C / 75% RH) + long-term data on request.
Analytical Methods
What we test on every batch.
| 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
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.
Each item below is backed by a current certificate or alignment assessment held by the Vialdyne 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.
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 — license verification on every request.