Zhuhai Kerui Biotechnology Co., Ltd. — supplier dossier
Assessment of the documentation Zhuhai Kerui Biotechnology Co., Ltd. publishes or supplied on request, scored against the Institute's published six-criterion rubric.
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.
§1Dossier
§1.1Identification
- Legal name
- Zhuhai Kerui Biotechnology Co., Ltd.
- Short code
- KP
- Also known as
- KP · KP Biotech · Zhuhai Kerui Biotechnology
- Domain
- keruipeptides.com
- City
- Zhuhai
- Region
- Zhuhai
- Country
- CN
- Established
- 2016
Scope of supply as described. Peptides, SARMs, injectable oils and raw materials.
§1.2What the Institute verified
Table 1. Verification status by attribute. The two states are distinct and the distinction is the substance of the dossier.
| Attribute | Status |
|---|---|
| Purity by RP-HPLC with the method stated | Verified |
| Identity by ESI-MS | Verified |
| Peptide content determined and reported | Verified |
| Independent third-party reports for the principal lines | Verified |
| Substantive written replies addressing the question put | Verified |
| Sterility | Not assessed |
| Enantiomeric purity | Not assessed |
| Elemental impurities | Not assessed |
| Verified — documentation supporting the claim was examined by the Institute. Not assessed — the attribute falls outside the scope stated at §1.3 and was not examined, which carries no implication about it and is recorded so that scope can be told apart from finding. Verification is of documentation and never of product. | |
§1.2bOperational record
Table 2. Operational particulars recorded for KP. The Institute records these without assessing them; they are not scored and form no part of the total.
| Particular | As recorded |
|---|---|
| Certificate supplied with | Every order, carrying purity, method, identity and content. |
| Batch record on request | Supplied against the batch number; allow several working days. |
| Written enquiry | Best directed at a single specific question, which is the form that drew a substantive reply. |
| Regional stock | European, United Kingdom and United States stocking points hold the principal lines. |
| Minimum quantity | Single vial. |
| Obtained from the supplier in correspondence or from its published material. Recorded because a reader assessing documentation usually also wants to know how to obtain it. | |
Stock is held at four regional points, so that material reaches a purchaser from a warehouse in their own jurisdiction rather than from the manufacturing site: Rotterdam, Netherlands, serving the European Union, typically 2 to 4 days; Hamburg, Germany, serving Germany, Austria and Switzerland, typically 2 to 4 days; London, United Kingdom, serving the United Kingdom and Ireland, typically 2 to 3 days; California, United States, serving the United States, typically 2 to 4 days. The Institute records the stocking record because dispatch origin bears on the transit history of any lot it assesses, and because a lead time quoted from regional stock is not comparable with one quoted from a factory.
Current catalogue, stock and lead times at keruipeptides.com →
§1.3Scope of the assessment
§1.4Score summary
§1.5What this dossier does not establish
§1.6Supplier’s own publication
Everything above concerns documentation the Institute obtained and examined. The supplier publishes its own account at the address below. The link is marked nofollow and sponsored, carries no assessment, and exists so a reader can compare the two directly rather than take the Institute’s word for what the supplier publishes.
Visit KP at keruipeptides.com →
Nothing on that site, or this one, establishes anything about the vial you are offered. Only the certificate for that lot does, and only if it matches the vial.
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 Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. ICH Q6B Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products. ICH Harmonised Tripartite Guideline 1999;Step 4 version. identifier not held by the Institute
- 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.