Trust document · 03 sections
This page is the operating manual behind every Certificate of Analysis we ship. Three sections below, in the order they happen on a real lot:
§01
COA release process
Five inspection layers, run in order.
§02
ISO/IEC 17025 lab partnership
An independent accredited lab, not in-house QC.
§03
Deviation-handling protocol
Out-of-spec → quarantine → disposition, in writing.
§01 · COA release process
Each layer assumes the prior one passed. We do not release on identity alone, and we do not release on purity alone — the panel has to close before a vial leaves the warehouse.
HPLC retention time + mass-spectrometry molecular ion
Confirms the peptide is what the vial label claims — not a near-isobar or a relabeled lot pulled from another program.
Catches — Mislabeling, lot substitution, salt-form drift between manufacturing sites.
Area-% against the internal reference standard
Full chromatogram released with the lot. Area-% purity, not a “≥95% tested” line buried in a PDF.
Catches — Synthesis byproducts, impurity carryover, degradation before release.
Full MS trace, observed m/z vs theoretical
Observed mass within tolerance of theoretical for every lot — trace published alongside the COA, not just retained on file.
Catches — Sequence variants, missed residues, oxidation, acetylation drift.
LAL endotoxin (EU/mg) · ICH Q3C Class 2 residual solvents
Run by the same accredited lab that ran identity, on the same panel. Both reports ship with the lot.
Catches — Gram-negative contamination, retained DMF / DCM / ACN above USP <467> limits — common in offshore APIs.
Manufacturing site → receiving → QC release → ship-out
Every vial traces to a manufacturing site, a receiving inspector, a release signature, and a hand-off timestamp. Flagged deviations travel with the lot — they are not deleted and not retroactively edited.
Catches — Reintroduced returns, undocumented repacking, post-release relabeling for the “research-use” channel.
Identity and release both run on the same accredited panel.
The same lab, the same signature path, the same documentation packet. We do not split identity and release across two providers — buyers see one chain of evidence per lot.
§02 · ISO/IEC 17025 lab partnership
ISO/IEC 17025 is the international standard that governs testing and calibration laboratories. It sets requirements for method validation, equipment calibration, traceability of measurements, and technical competence of staff. An accredited lab is audited against that standard by an independent accreditation body — it is not a self-declaration.
Method validation
Every method on our panel — HPLC, MS, LAL, residual solvents — is validated per ICH Q2(R2) and documented in a method file that the lab publishes on request. The validation is not the lot data; the lot data is run against validation that already happened.
Calibration + traceability
Reference standards traceable to NIST where applicable. The HPLC UV detector, the mass spectrometer, and the LAL reader are all on scheduled calibration intervals — calibration records are part of the lot packet, not behind a separate request.
Independent technical competence
The lab employs the analysts, signs the COA, and keeps the raw data. We cannot and do not re-run their panel to override a result. If a reading is marginal, the lab is who we work with to investigate — not who we negotiate with to change the document.
Why not in-house QC
A pharma-grade peptide panel run by the distributor itself is a self-test, and an inspector can reasonably ask whether the test was set up to confirm a foregone conclusion. ISO/IEC 17025 is the answer that survives that scrutiny — the panel is run by a third party who can lose their accreditation over a bad result.
Lab-of-Record Reference
What the panel call-out looks like on every lot passport.
The lab’s public-facing identity (legal name, accreditation body, certificate number) is published on the COA header of every released lot. On this page we use the lab-of-record short reference A2-17025 — the in-line label buyers see on a real lot passport.
§03 · Deviation-handling protocol
A deviation log is not a defect to be erased. It is the record that proves a lot was inspected honestly. The protocol below is what runs every time any layer on the panel flags out-of-spec, in any lot, in any manufacturing campaign.
Any panel reading outside acceptance criteria — HPLC impurity, MS mismatch, LAL above limit, RS above ICH Q3C — is flagged by the lab analyst at the moment of result entry. The lab does not “round into spec,” and the result is not paraphrased in the COA.
Material is moved from releasing inventory to a physically segregated quarantine area. No vial from the lot ships until disposition is recorded. Receiving inspectors stop signing the lot in.
The lab-of-record, a Stratum QC reviewer, and a sponsor-side manufacturing contact trace the deviation chain: from sample prep and instrument calibration, back through synthesis campaign and source powder. Findings are written up before any disposition is chosen.
Every deviation resolves to one of three outcomes, in writing: (a) rework — reprocess and re-test under the same panel; (b) downgrade — re-classify to research-grade only, never pharmacy-grade; (c) reject — destroy and document destruction. No fourth outcome exists.
The deviation record travels with the lot passport on the certificate. If a lot was dispositioned as “rework” and re-released, the prior record is preserved — buyers see the original deviation, the remediation, and the re-test results on a single artifact.
Deviations travel with the lot. They are never silently corrected.
If a lot was dispositioned as rework and re-released, the original deviation, the remediation, and the re-test results are all on the same artifact. Buyers see the full history, not a sanitized final reading.
Verify before you order
Provenance is public because it should be. The live catalog — current lot numbers, in-stock panel results, pricing — only opens for verified 503A / 503B pharmacies, telehealth providers, and clinical operators.