What the label states, the lot delivers — net peptide mass, not gross powder weight, purity reported as measured rather than rounded up, and a Certificate of Analysis for every lot.
Net peptide mass, not powder weight; purity as measured, not rounded up; a COA per lot.
Net peptide + purity not rounded up. COA per lot.
FDA PCAC reviews 7 peptides for the 503A bulks list (BPC-157, KPV, TB-500, MOTs-C, Emideltide, Semax, Epitalon). Read our compounder's decision tree. Read our briefing →
FDA PCAC reviews 7 peptides for the 503A bulks list in July. Read →
FDA PCAC: 7 peptides under review. Read →
Release Documentation
A compounding pharmacy is not buying powder — it is buying a lot it can release into a patient preparation. So the documentation comes first here: what ships with the lot, the specification it was dispositioned against, and how it maps to the standard you file under.
Released-batch vials · Shanghai facility · post-QA hold
Quality You Can Verify
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
<24h
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.
Published Certificates
Real released-batch certificates, every lot HPLC-verified. These are previews — request the full high-resolution COA for any batch.
VerifiedRequest full COA →Tirzepatide
VD260428-TR216 · 99.32%
VerifiedRequest full COA →Retatrutide
VD260428-RT170 · 99.33%
VerifiedRequest full COA →Semaglutide
VD260428-SM177 · 99.45%
VerifiedRequest full COA →BPC-157
VD260428-BC10035 · 98.94%
VerifiedRequest full COA →TB-500
VD260428-TB10195 · 98.88%
VerifiedRequest full COA →MOTS-c (Human)
VD260428-MS10139 · 99.48%
VerifiedRequest full COA →GHK-Cu
VD260428-CU100078 · 99.22%
VerifiedRequest full COA →CagriSema
VD260428-CS20039 · 99.17%
VerifiedRequest full COA →NAD+ (Nicotinamide Adenine Dinucleotide)
VD260428-NJ1000145 · 99.27%
VerifiedRequest full COA →GLOW Multi-Peptide Complex
VD260428-GLOW70084 · 99.27%
VerifiedRequest full COA →KLOW Multi-Peptide Complex
VD260428-KLOW80119 · 99.19%
VerifiedRequest full COA →Ipamorelin
VD260428-IPA10116 · 99.53%
What arrives with the lot
Every Vialdyne lot dispatches with its Certificate of Analysis, its LAL endotoxin certificate, and its residual-solvents statement. The rest of the release packet — chromatograms, spectra, stability data, sequence verification, SDS — is produced for qualified buyers on request, so your QA file can be as deep as your filing requires without paperwork you do not need.
Per-lot. Carries HPLC purity, mass-spec identity, water content, and microbiology for the exact batch shipped.
Bacterial endotoxin result for the lot, tested for sterile-compounding use.
GC-headspace result against ICH Q3C class limits for the lot.
Raw trace showing the main peak and the impurity profile behind the COA purity figure.
ESI-MS confirmation of molecular mass within ±0.5 Da of theoretical.
Accelerated (40 °C / 75 % RH) and long-term real-time data supporting the assigned re-test date.
Independently verified amino-acid sequence for peptides longer than 15 aa.
Safety data sheet for handling and storage in your facility.
The release specification
Before QA signs a lot for release, it is measured against the criteria below — the same line items your incoming-material review will reconcile our COA to. Analytical methods are aligned with USP <1225>. The endotoxin and microbial criteria are what make a lot defensible for sterile compounding use.
| Quality attribute | Method | Acceptance criterion |
|---|---|---|
| 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 |
Criteria shown are the standard catalog specification; tighter limits for a specific preparation are agreed per program during qualification.
Mapped to your filing
Each signal below is a documentation posture Vialdyne can back with an artifact a qualified buyer can audit. They are worded to map onto the framework you compound under — USP <797> / <800> for a 503A pharmacy, ICH Q1A stability and DMF / ASMF support for a 503B program, EU GMP Annex 1 for an EU compounder. The lot data is the same; the wrapper matches your filing.
Qualifying a lot
Bringing on a new API source is a QA exercise, not a checkout. Here is the path from your first sample COA to a standing-order relationship where every lot arrives documented.
Send your catalogue request with your license class. We return a representative COA, the endotoxin / bioburden spec, and an ICH stability summary so your QA team can review the format before any material moves.
Receive a sample lot with its own per-lot release packet. Reconcile the COA against your acceptance criteria and, if you wish, against your own incoming-material testing.
We agree the release specification and the documentation wrapper that matches your filing — 503A, 503B, EU Annex 1, or distributor — under mutual NDA / supply terms.
Place repeat orders against a standing template. Each lot ships with its COA and the documents you specified, and the regulatory / sales review answers documentation questions inside 24 hours.
First response under 24 hours · Catalog · Sample COA · MOQ · Lead time. Our regulatory and sales teams review every inquiry before pricing — license verification on every request.
