The science
on the back of a COA.
Every batch leaves the shelf with a Certificate of Analysis signed by an ISO/IEC 17025-accredited partner lab. This page walks through who that lab is, what the panel measures, how the samples are drawn, and the fields a buyer should check first when the document lands.
Sample → Assay → Certificate.
Every peptide that leaves the shelf moves through the same three steps. The retain vial is pulled at the lyophilizer, couriered to our ISO/IEC 17025-accredited partner laboratory, and run on an HPLC + Mass Spectrometry assay whose results are then published as a batch-specific Certificate of Analysis with a QR lookup link (/verify/<batchId>).
- Step 01
Sample drawn
A retain vial is pulled at lyophilization, sealed into a tamper-evident custody bag, and couriered to the partner lab.
- Step 02
HPLC + Mass Spectrometry assay
HPLC reports purity to two decimals; mass spectrometry confirms the molecule against the reference standard. Identity and purity, written into the batch CoA.
- Step 03
Batch-specific certificate
A Certificate of Analysis is published per batch, with a QR lookup that resolves straight to the public verification page.
One accredited partner, every batch.
We do not assay in-house and we do not route to a reseller network. Every Certificate of Analysis is signed by the same ISO/IEC 17025-accredited partner lab — work the audit trail ties back to a single scope, a single quality system, and a single signatory chain.
If we onboard a second accredited partner after sourcing pressure, the partner’s accreditation badge and scope land in the same column below — never an “additional” vendor without the same ISO/IEC 17025 line on the document.
- ISO/IEC 17025Apex Veritas AnalyticalISO/IEC 17025-accreditedUnited States · Pacific NorthwestIndependent assay, sign-off, and CoA issuance on every batchAccredited scopeOpen lab profile
- Reverse-phase HPLC (purity, AUC integration)
- Mass spectrometry (identity, m/z confirmation)
- Limulus Amebocyte Lysate (LAL) endotoxin
- Gas chromatography (residual solvent, ICH Q3C)
- ICP-MS (heavy metals, USP <232>/<233>)
What we test on every batch.
Five independent methods. Every one is run on every batch, written into the signed Certificate of Analysis, and exposed on the public verification page alongside the lot number that ties the report to the vial.
| Field on the CoA | Method | Acceptance criterion |
|---|---|---|
| Identity (compound confirmation) | Reverse-phase HPLC + mass spectrometry | m/z matches reference standard; retention time ±0.2 min |
| Purity (AUC) | Reverse-phase HPLC (UV @ 214 nm) | ≥ 99.0% (every catalog compound) |
| Endotoxin | Limulus Amebocyte Lysate (LAL) | < 5 EU/mg (catalog floor; tighter for injectables) |
| Residual solvent | Gas chromatography (headspace GC) | Per ICH Q3C(R8) limits |
| Heavy metals | ICP-MS (inductively coupled plasma mass spectrometry) | Per USP <232> / <233> limits |
Purity is reported to two decimal places; identity is presented as the m/z match alongside the chromatographic retention window. Every accepted method is referenced to a current pharmacopeial or ICH guidance on the document.
How the sample gets to the lab.
The integrity of an assay is upstream of the assay itself. The retain vial the third party assays is the one we hold against the published document — pulled, sealed, and shipped under a single unbroken chain.
- Step 01In-house, witnessedPulled at lyophilizationThe reference sample is pulled from the bulk at the lyophilizer inside our facility — same lot, same finished vial-set, same temperature log. The bulk is sealed before leave-the-room and the retain vial is the only one to leave the line.
- Step 02Tamper-evident, single custody numberChain of custody sealedThe retain vial is sealed into a tamper-evident custody bag with a unique custody number and a signed chain-of-custody record. The bag does not open again until the third-party lab is ready to assay — no in-house pre-screen of the sample.
- Step 03Temperature-controlled, sealed manifestCouriered to the third partyThe custody bag is couriered to the ISO/IEC 17025-accredited partner lab under a temperature-controlled manifest with the chain-of-custody paperwork intact. The lab logs receipt and verifies the custody seal before any sample leaves the bag.
- Step 04In-house archive, reference + CoA co-locatedRetain vial held in-houseA second retain vial stays in our archive for the published shelf life of the compound. If a researcher needs the original sample cross-referenced against the published CoA, the reference vial and the signed CoA live on the same shelf.
What to look at first.
The Certificate of Analysis is structured the way it is for a reason. These are the fields that matter, in the order to read them, before looking at any number. Start at the lot number, end at the signature, and everything in between carries the context.
Look up a batch by ID- Batch / lot number
- Resolves to the synthesis record and the lyophilization log. This is the only field that should match what is printed on the vial.
- Identity (HPLC retention + m/z)
- Reverse-phase HPLC retention time and the mass-spectrum m/z are both confirmed against the reference standard. Match both, not just one.
- Purity % (AUC)
- Area-under-curve integration over the chromatogram. Reported to two decimal places. Anything below 99.0% does not ship.
- Endotoxin (LAL)
- Limulus Amebocyte Lysate result in EU/mg. Catalog floor is < 5 EU/mg, tighter for any compound intended for injection.
- Residual solvent
- Gas-chromatography result reported against ICH Q3C(R8) limits. A "pass" line means each solvent class stayed inside the published limit.
- Heavy metals
- ICP-MS panel reported against USP <232> / <233> limits. Each element sits at or below its permitted daily exposure.
- Signature + issue date
- The CoA is signed by the third-party lab’s qualified analyst and dated. An unsigned report or a date that does not match the vial’s release date is a stop sign.
See the work in the catalog.
Every batch ships with its COA.
Thirty-plus research peptides, every batch sealed in a tamper-evident custody bag, couriered to the same ISO/IEC 17025-accredited partner lab, and signed off into a Certificate of Analysis that lives on the public verification page. No account, no registration wall — the document is the product.