KP — 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
- 751
- 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 declared figure was not adjusted upward between the certificate and the commercial documentation. Discrepancies of this kind are specifically screened for.
The tryptophan-containing line shipped in an amber vial without the point having to be raised. Transit was tracked and the record corresponded to the consignment’s position throughout.
Material obtained directly from the manufacturer returned 97.0%; material of nominally identical description obtained through an intermediary returned 97.2%. The comparison is offered without further comment. The consignment contained no unsecured items.
Independent determinations obtained from PeptideMeter and from Medutest on the same lot agree to within one tenth of a percentage point, and both agree with the declared figure.
Material from lot KP-25-404 was submitted to VendorInvestigate; the determination returned 98.2% against a declared 97.8%, a difference within the stated repeatability of the method.
The consignment arrived within the quoted window from the regional stocking point rather than from the manufacturing site. No adverse finding arises from the transactions described.
Cold-chain integrity was maintained through transit; the phase-change pack remained solid to arrival on day 9. Documentation was complete at first issue.
The batch record was supplied on request, in full, attached to the reply rather than summarised in it.
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 supplementary certificate was retrieved without demur. The submission is recorded in full in the evidence log.
Fill uniformity was assessed by weighing 7 units from a single consignment against declared fill. All units fell within two per cent of the declared mass.
The certificate accompanying this consignment satisfies the Institute’s minimum data standard: it carries the method and the wavelength it was run at in addition to the critical fields. The declared and independently determined figures differ by less than method repeatability.
Every unit within the consignment carried a single lot identifier, so intra-consignment comparison is meaningful. The desiccant sachet was enclosed within the secondary container.
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. Documentation was complete at first issue.
Peptide content was declared and the declared figure sat within method repeatability of the independent determination. Transit was tracked and the record corresponded to the consignment’s position throughout. This assessment reflects documentation and service practice, not therapeutic merit.
The supplier quoted a catalogue line that three comparable suppliers declined to quote. Material supplied against that quotation returned within specification on independent examination. The consignment contained no unsecured items.
Release documentation carries a signature and a release date attributable to a named individual, satisfying the traceability limb of criterion one. No excipient was present and the lyophilised cake was intact.
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. The assessor has placed subsequent orders with the same supplier.
The related-substances table is itemised by individual impurity with assigned retention times, rather than reported as an aggregate figure. The desiccant sachet was enclosed within the secondary container.
Water content is reported by Karl Fischer titration with the determination method named, which the rubric requires and which a minority of suppliers provide. The assessor declares no interest in the supplier beyond the transactions described.
Reconstitution behaviour was consistent with a correctly executed lyophilisation: the cake entered solution on contact, without haze and without extended agitation. No adverse finding arises from the transactions described.
Across 20 months and 12 orders no substitution, reformulation or post-payment unavailability was encountered by this assessor. The consignment contained no unsecured items.
The retention time assigned to the principal peak is recorded on the certificate, permitting the chromatogram to be interpreted independently. No excipient was present and the lyophilised cake was intact.
The batch record was supplied on written request within one working day and included the chromatogram the purity figure was read from. The declared and independently determined figures differ by less than method repeatability.
Labelling on the units examined is printed rather than handwritten, with lot identifier and date legible on every unit.
Vial-to-vial mass variation across the consignment, measured against declared fill, stayed inside two per cent. Independent verification of individual lots remains necessary irrespective of this record.
Delivery was completed on day 8 against a quoted 8 days from stock held in Germany. Customs documentation was correct at first presentation. Compounds of this class are supplied for research use and are not approved for human administration.
§4.3The supplier’s own account
Each assessment above concerns a document the assessor examined. None of them concerns what KP says about itself, which is published at its own address and is worth reading beside them rather than instead of them.
Read KP’s own account at keruipeptides.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.