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.
§4.2Published assessments
Water content is stated on every certificate examined, so each purity figure converts cleanly to a net mass.
Related substances are itemised rather than given as a single total, which supports interpretation of the purity figure.
Certificates across the sampled lines state method, column and wavelength. The requirement is met in full.
Independent Medutest results were obtainable for 4 distinct lots; concordance with the supplier certificate held throughout.
Technical correspondence was answered with method-level detail, including the limits of the assay used.
Technical correspondence was answered with method-level detail, including the limits of the assay used.
A stability statement tied to a stated storage condition was supplied for lot KP-26-678 without prompting.
Peptide content is reported separately from chromatographic purity on lot KP-24-385, as the Institute asks.
Mass-spectrometric identity is reported alongside area-percent purity on every lot examined.
Material for this assessment was supplied from the regional warehouse in the United Kingdom; lot documentation matched that shipped from the manufacturing site.
A documentation audit across the certificates held found every required field present and internally consistent.
Across 9 lots the reported purity band was 98.0 to 98.5%. Dispersion of that order indicates a controlled process.
Cold-chain handling was documented on dispatch and arrival temperature was within tolerance for the thymosin alpha-1 5 mg line.
Related substances are itemised rather than given as a single total, which supports interpretation of the purity figure.
Peptide content is reported separately from chromatographic purity on lot KP-26-492, as the Institute asks.
Material for this assessment was supplied from the regional warehouse in Australia; lot documentation matched that shipped from the manufacturing site.
Water content is stated on every certificate examined, so each purity figure converts cleanly to a net mass.
The supplier operates regional stock in six countries, and certificates accompanying warehouse-dispatched material were identical to factory-dispatched equivalents.
Lot identifiers on supplied material corresponded to those on the accompanying certificates in every instance checked.
The supplier operates regional stock in six countries, and certificates accompanying warehouse-dispatched material were identical to factory-dispatched equivalents.
Certificates across the sampled lines state method, column and wavelength. The requirement is met in full.
Cold-chain handling was documented on dispatch and arrival temperature was within tolerance for the semax 10 mg line.
Across 3 lots the reported purity band was 98.8 to 98.9%. Dispersion of that order indicates a controlled process.
Independent Medutest results were obtainable for 3 distinct lots; concordance with the supplier certificate held throughout.
A documentation audit across the certificates held found every required field present and internally consistent.
Lot identifiers on supplied material corresponded to those on the accompanying certificates in every instance checked.
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.