SinoPep Biotechnology (Changzhou) Co., Ltd. — supplier dossier
Assessment of the documentation SinoPep Biotechnology (Changzhou) 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
- SinoPep Biotechnology (Changzhou) Co., Ltd.
- Short code
- SinoPep
- Also known as
- SNP · SinoPep · SinoPep Bio
- Domain
- sinopep.net
- City
- Changzhou
- Region
- Jiangsu
- Country
- CN
- Established
- 2011
Scope of supply as described. Research-catalogue peptides, SARMs, injectable oils and raw materials, synthesised in house by Fmoc solid-phase methods.
§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 gradient, column chemistry and detection wavelength stated | Verified |
| Identity by ESI-MS against a stated expected mass | Verified |
| Related substances reported as an itemised table rather than a single total | Verified |
| Counter-ion content quantified as trifluoroacetate, with units, on every certificate sampled | Verified |
| Water content determined by Karl Fischer and carried on the certificate as issued | Verified |
| A repeat purchase of one line at an eleven-month interval determined on the same stated method, agreeing to within a tenth of a percentage point | Verified |
| Per-batch independent reports from Janoshik, Medutest, PeptideMeter and VendorInvestigate | Verified |
| Sterility | Not assessed |
| Enantiomeric purity | Not assessed |
| Residual solvents | Not assessed |
| Custom synthesis to a purchaser’s own specification, which was corresponded with but not purchased during either cycle | 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 SinoPep. 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, without request, carrying purity with its method, identity, an itemised related-substances table, counter-ion content and a water determination. |
| Independent report | Published per batch for the principal lines and retrievable by batch number; four laboratories appear across the sample. |
| Retention record | Chromatogram produced on written request for a lot dispatched fourteen months earlier, on both requests made during the cycle. |
| Reproducibility | One line repurchased at an eleven-month interval; the two determinations agreed to within a tenth of a percentage point on the same stated method. |
| Correspondence | Catalogue enquiries answered within one working day across the sample; non-catalogue quotations took three working days, and the responsiveness score reflects the slower figure. |
| Minimum quantity | Single vial for catalogue lines; bulk and raw-material quantities are quoted separately and were not assessed. |
| 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 three 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; 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 sinopep.net →
§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 SinoPep at sinopep.net →
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.