Ask sales for the Certificate of Analysis matched to the offered or supplied lot; it records the tests actually completed, applicable specifications, and reported results.
Review the matching batch COA for the analytical scope and results recorded for that lot.
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
Review the applicable batch record.
Ask sales for the COA matched to the offered or supplied batch. It records the tests actually completed. Route-specific methods, raw data, and independent reports are separate agreed scopes.
≥99%
Purity by HPLC
100%
Per-batch COA
<24h
Doc response
Batch COA available from sales for the relevant lot.
LAL endotoxin + microbial limits for sterile compounding-pharmacy use.
ICH Q1A stability, accelerated (40°C / 75% RH) + long-term data on request.
These are certificate previews. Ask sales for the batch COA matched to the offered or supplied lot; it shows the tests completed and the reported results.
Professional third-party testing in Tianjin, matched by product.
Independent HPLC and mass-spectrometry reports from Qorix , the professional, authoritative third-party analytical laboratory at tjqxgd.com, affiliated with the Tianjin International Joint Academy of Biomedicine.
Preview reports for eight of the most-requested matched products.
Need a complete, clear Batch COA or third-party report?
Send us the product and document type. Sales will confirm the applicable lot, batch, or report number and provide the latest available full-resolution document.
Batch COA available. Expanded documentation by agreement.
Ask sales for the Certificate of Analysis corresponding to the lot offered or shipped. It records the tests performed, applicable specifications, and results for that lot. Raw chromatograms, spectra, stability data, sequence verification, endotoxin, microbial limits, residual-solvent statements, and SDS documents are provided when included in the agreed analytical and documentation scope.
Batch COA
Certificate of Analysis
Per-lot record of the tests performed, applicable specifications, and reported results; available from sales for the lot offered or shipped.
Agreed scope
LAL endotoxin certificate
Bacterial endotoxin result when included in the agreed analytical scope.
Agreed scope
Residual solvents statement
GC-headspace result against agreed ICH Q3C limits when required for the lot.
Agreed scope
HPLC chromatogram
Raw trace showing the main peak and the impurity profile behind the COA purity figure.
Agreed scope
Mass-spec spectrum
ESI-MS confirmation of molecular mass within ±0.5 Da of theoretical.
Agreed scope
ICH Q1A stability data
Accelerated (40 °C / 75 % RH) and long-term real-time data supporting the assigned re-test date.
Agreed scope
Sequence verification report
Independently verified amino-acid sequence for peptides longer than 15 aa.
Agreed scope
SDS
Safety data sheet for handling and storage in your facility.
The attributes below are a qualification map, not a promise that every method applies to every product. The matching batch COA states what was actually completed; route-specific or expanded work must be agreed before quotation.
Quality attribute
Method
Acceptance criterion
HPLC purity
Method stated on the applicable batch COA
Per agreed lot specification
Identity
Method stated on the applicable batch COA
Per agreed lot specification
Peptide content
When included in the agreed scope
Per agreed lot specification
Water content
When included in the agreed scope
Per agreed lot specification
Counter-ion
When included in the agreed scope
Per agreed lot specification
Bacterial endotoxin
Route-specific; agree before quotation
Per agreed lot specification
Microbial limits
Route-specific; agree before quotation
Per agreed lot specification
Residual solvents
When included in the agreed scope
Per agreed lot specification
The offered lot's COA and the signed order scope are authoritative. Buyer-requested independent testing is optional and buyer-funded unless otherwise agreed in writing.
Mapped to your filing
The documentation lines up with what you file.
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.
Certificate numbers, validity periods & inspection reports — under mutual NDA on qualified RFQ
cGMP-Scoped API Docs
< 5 EU/mg Endotoxin
ICH Q1A Stability
USP <797> / <800> Aware
Annex 1 Documentation Map
DMF/ASMF Support on Request
Qualifying a lot
Four steps from sample to standing supply.
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 each supplied lot can be traced to its matching batch COA.
01
Request the sample COA + spec
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.
02
Qualify a sample lot
Receive a sample lot and request its batch COA from sales. Reconcile the recorded results against your acceptance criteria; any incoming-material testing required by your own SOP remains optional and is not a Vialdyne condition of purchase.
03
Set acceptance criteria & onboard
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.
04
Standing supply, lot data each time
For repeat orders, ask sales to confirm the current lot and provide its matching COA. Any additional documents remain governed by the written order scope, and documentation questions are handled through the regulatory / sales review.
Let's talk peptides.
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.
