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Quality standards

Our quality standards

Quality in a research supply chain is a sequence of checkpoints, each with a written pass condition and a record. This page describes the checkpoints applied to our material and the evidence each one produces.

Last updated August 5, 2026StandardsReviewed by the PrimeGen Co. laboratory documentation team

Release criteria

A lot is only listed once every criterion below has been met and recorded. A failure at any stage halts the lot; material is either reworked through additional purification or withdrawn.

Release criteria applied per lot
AttributeMethodRelease condition
Chromatographic purityReversed-phase HPLC, UV detectionMeets the stated product specification
IdentityMass spectrometryObserved mass consistent with the theoretical mass
AppearanceVisual inspection against a written standardUniform lyophilized cake, free of visible particulates
Fill weightGravimetric check across the fill runWithin the declared tolerance of nominal fill
Closure integritySeal inspectionCrimped seal intact, stopper fully seated
Label accuracyReconciliation against the fill recordProduct, strength, lot and dates match the record
Release criteria applied per lot

The review sequence

Each stage below has a named owner and produces a document that becomes part of the lot record. No stage can be skipped by exception; if a step is repeated, both the original and the repeat are retained.

  1. 01Incoming material checkRaw materials and consumables are logged against supplier documentation before use.
  2. 02In-process monitoringSynthesis and purification steps are monitored so that failures surface during production rather than at final analysis.
  3. 03In-house analysisPurified material is assayed by RP-HPLC for chromatographic purity.
  4. 04Independent verificationA sample is submitted to an unaffiliated analytical laboratory for HPLC and mass spectrometry.
  5. 05Fill and label reconciliationFilled vial count, label count and the fill record are reconciled before release.
  6. 06Documentation reviewThe complete record is reviewed and the certificate is published against the lot number.

Deviations and retained samples

Deviations are recorded rather than resolved informally. A deviation entry states what was observed, what was done and who authorised the disposition, and it stays attached to the lot record permanently.

Retained samples are held from each lot under the same storage conditions as the released material. If a question is raised months later, it can be answered against original material rather than a reconstruction.

Frequently asked questions

What happens to a lot that fails a release criterion?

It is held. Depending on the failure it is either reworked through additional purification and re-assayed as a new lot, or withdrawn. Failing material is not blended into a passing lot.

Is the independent laboratory the same one every time?

Independent verification is performed by unaffiliated analytical laboratories; the analysing laboratory is named on the report supplied for each lot.

Related research compounds

Compounds with a published certificate of analysis, where the methodology described on this page can be read against a real lot record.

Related reading

References and standards

Editorial attribution

PrimeGen Co. laboratory documentation team

Editorial and analytical documentation

Our documentation team maintains lot records, certificate presentation and the educational material on this site. Pages describe our own internal practices and published analytical methodology; they are not an independent certification of any kind.