QST — on-the-record assessments
Signed assessments of the documentation examined, with the aggregate rating and its scope.
The Institute assesses documentation, not product. It has purchased nothing, tested nothing and inspected nothing. Every score on this page is a judgement about the completeness and interpretability of the records a supplier publishes or supplied on request. A high score means that a supplier documents its material well. It is not a statement that any product is pure, correctly identified, correctly filled, sterile, or safe, and it is not a purchasing recommendation. The Institute makes no purchasing recommendations.
§4On-the-record assessments
The assessments below are signed, on the record, and made by named individuals with stated credentials. Each concerns the documentation the assessor examined. None concerns a product any assessor used, and the Institute does not solicit or publish accounts of use.
§4.1Aggregate
- Modal certainty across assessments
- High
- Assessments contributing
- 488
- Assessments published in full
- 26
- Scope of the rating
- Documentation completeness and interpretability. Not product quality.
- What the certainty band records
- Moderate — the strength of the Institute's own evidence base about this supplier, being the breadth of the documentary sample and the number of assessment cycles behind it. It is not a quality verdict and nothing on this site presents it as one.
§4.2Published assessments
The retention time assigned to the principal peak is recorded on the certificate, permitting the chromatogram to be interpreted independently. This is a single assessor’s record and carries the weight the rubric assigns to one.
Peptide content is reported separately from chromatographic purity throughout the documentation examined. The distinction is maintained consistently across the 11 certificates held. Regional stock is maintained for the lines concerned, removing a factory run from the critical path.
The storage condition against which the stability statement was written is stated on the certificate, which permits the statement to be evaluated rather than merely noted. The reorder placed at 15 months returned a figure within one tenth of a point of the original. The assessor declares no interest in the supplier beyond the transactions described.
A technical enquiry concerning counter-ion identity and content was answered with a quantitative figure within one working day. Responses of this character are recorded because they are uncommon. Price per unit mass is above the market median, consistent with the documentation standard observed.
Material obtained directly from the manufacturer returned 99.2%; material of nominally identical description obtained through an intermediary returned 99.2%. The comparison is offered without further comment. Catalogue availability corresponded to the published catalogue.
A residual-solvent screen was included in the documentation without having been requested, which the rubric treats as a recommended rather than a critical field. The PeptideMeter report is held on file and corresponds to the figures published by the supplier.
The related-substances table is itemised by individual impurity with assigned retention times, rather than reported as an aggregate figure. The technical response was received within four hours on a working day. Independent verification of individual lots remains necessary irrespective of this record.
Material from lot QST-26-489 was submitted to Janoshik; the determination returned 97.8% against a declared 97.5%, a difference within the stated repeatability of the method. Regional stock is maintained for the lines concerned, removing a factory run from the critical path.
Batch traceability is complete: the identifier on the primary container corresponds to that on the certificate and to that on the commercial documentation. Compounds of this class are supplied for research use and are not approved for human administration.
The quotation returned with the vial size, the quantity and the unit price as requested, and the price held to invoice. Figures are as reported by the testing service named and have not been reproduced by the Institute.
Vial-to-vial mass variation across the consignment, measured against declared fill, stayed inside two per cent. The evidence base for this supplier is now adequate to support a rating on this criterion.
The line was quoted from regional stock with a stated lead time, and the stated lead time was met. The Medutest report is held on file and corresponds to the figures published by the supplier. Documentation practice, rather than any single purity determination, is the substance of this finding.
The declared figure was not adjusted upward between the certificate and the commercial documentation. Discrepancies of this kind are specifically screened for. The technical response was received within four hours on a working day. No adverse finding arises from the transactions described.
Water content is reported by Karl Fischer titration with the determination method named, which the rubric requires and which a minority of suppliers provide. Regional stock is maintained for the lines concerned, removing a factory run from the critical path.
A repeat determination on the same catalogue line at 24 months returned 97.0%, against 97.0% originally. No evidence of process drift is present in this sample. This is a single assessor’s record and carries the weight the rubric assigns to one.
Dispatch occurred inside the quoted window and the tracking reference resolved from the moment it was issued. Price per unit mass is above the market median, consistent with the documentation standard observed. Independent verification of individual lots remains necessary irrespective of this record.
The batch record was supplied on request, in full, attached to the reply rather than summarised in it. Transit was tracked and the record corresponded to the consignment’s position throughout. Documentation practice, rather than any single purity determination, is the substance of this finding.
Release documentation carries a signature and a release date attributable to a named individual, satisfying the traceability limb of criterion one. The VendorInvestigate report is held on file and corresponds to the figures published by the supplier.
A supplementary certificate covering a lot released 24 months previously was produced from the supplier’s records on request, indicating that release records are retained rather than reconstructed.
Consistency across lots was assessed over 12 determinations. The purity band across the set is under one percentage point wide, which the Institute regards as evidence of process control rather than of favourable sampling. Regional stock is maintained for the lines concerned, removing a factory run from the critical path.
Packing was assessed as adequate to the transit undertaken: a rigid outer with no rattle anywhere in it. The reorder placed at 15 months returned a figure within one tenth of a point of the original.
A request for the expected mass against which identity had been assigned was answered the same working day with the figure. Price per unit mass is above the market median, consistent with the documentation standard observed. No adverse finding arises from the transactions described.
Independent determinations obtained from Janoshik and from VendorInvestigate on the same lot agree to within one tenth of a percentage point, and both agree with the declared figure. Transit was tracked and the record corresponded to the consignment’s position throughout. Nothing in this submission constitutes medical advice.
Documentation was complete at first issue. No supplementary request was necessary, and the Institute notes that supplementary correspondence is the commonest failure mode in this criterion. The Janoshik report is held on file and corresponds to the figures published by the supplier.
Delivery was completed on day 5 against a quoted 5 days from stock held in Australia. Customs documentation was correct at first presentation. The desiccant sachet was enclosed within the secondary container.
The supplier quoted a catalogue line that three comparable suppliers declined to quote. Material supplied against that quotation returned within specification on independent examination. Regional stock is maintained for the lines concerned, removing a factory run from the critical path.
§4.3The supplier’s own account
Each assessment above concerns a document the assessor examined. None of them concerns what QST says about itself, which is published at its own address and is worth reading beside them rather than instead of them.
Read QST’s own account at qingdaosabertechnology.com →
References cited on this page
References are numbered in order of first citation in this document. Each superscript in the text links to its entry below.
- International Organization for Standardization. ISO/IEC 17025:2017 General Requirements for the Competence of Testing and Calibration Laboratories. ISO/IEC Standard 2017;3rd edition. identifier not held by the Institute
Identifiers are reproduced only where the Institute holds them. Where a digital object identifier or PubMed identifier is not shown, the Institute has recorded the journal and year and has not constructed an identifier.