Sangon Biotech: difference between revisions
Diff·revision 37 → 38·17:31, 5 Aug 2025
Difference between revision 37 and revision 38 of Sangon Biotech. 6 lines changed; the page grew by 991 bytes.
| Revision 37 — 03:50, 27 Jul 2025 SPPS_Sorrel (talk) ce, tighten prose 8,645 bytes +783 | Revision 38 — 17:31, 5 Aug 2025 VerifyFirstVida (talk) expand §Product range 9,636 bytes +991 | ||
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| 68 | * '''It is not comparable across communities.''' Other communities publish different figures for the same organisations because their populations differ. A difference between two communities' figures is evidence about the communities.{{r|tally}} | 68 | * '''It is not comparable across communities.''' Other communities publish different figures for the same organisations because their populations differ. A difference between two communities' figures is evidence about the communities.{{r|tally}} |
| 69 | 69 | ||
| + | 70 | == Regulatory position and legal status == | |
| + | 71 | The organisation is a commercial entity registered in the People's Republic of China. Nothing in the available record indicates a manufacturing authorisation, marketing authorisation or pharmacopoeial registration in any jurisdiction, and none should be inferred from a registered business scope, which is a licensing fact and not a quality assurance.{{r|registry}} | |
| + | 72 | ||
| + | 73 | Material labelled [[Research use only|for research use only]] is outside the regulatory framework that governs medicines. Its identity, purity, sterility and [[Bacterial endotoxin test|endotoxin]] content are not assured by any regulator, and a [[Certificate of analysis|certificate of analysis]] issued by a supplier is a claim by that supplier rather than an independent finding.{{r|ruo,usp1503}} | |
| + | 74 | ||
| 70 | == References == | 75 | == References == |
| 71 | {{reflist}} | 76 | {{reflist}} |
| ⋮ | ⋮ | ||
| 74 | <ref name="reports">Independent test reports submitted to PeptidePedia by purchasers, 2024–2026. Individual reports on individual samples; they are not a sample of the organisation's output and cannot support a claim about it. See [[Blind sampling]].</ref> | 79 | <ref name="reports">Independent test reports submitted to PeptidePedia by purchasers, 2024–2026. Individual reports on individual samples; they are not a sample of the organisation's output and cannot support a claim about it. See [[Blind sampling]].</ref> |
| 75 | <ref name="tally">PeptidePedia reception tally (self-reported submissions; '''weak evidence''' — see [[Project:Sourcing guidelines]]). Self-selected sample; period and count stated at each point of use.</ref> | 80 | <ref name="tally">PeptidePedia reception tally (self-reported submissions; '''weak evidence''' — see [[Project:Sourcing guidelines]]). Self-selected sample; period and count stated at each point of use.</ref> |
| + | 81 | <ref name="usp1503">United States Pharmacopeia, General Chapter <1503>, "Quality Attributes of Synthetic Peptide Drug Substances" (informational). USP–NF, current revision.</ref> | |
| 76 | <ref name="ruo">Research-use-only labelling practice; see [[Research use only]] for the legal and commercial function of the phrase.</ref> | 82 | <ref name="ruo">Research-use-only labelling practice; see [[Research use only]] for the legal and commercial function of the phrase.</ref> |
| 77 | <ref name="gmp">World Health Organization, ''Good Manufacturing Practices for Pharmaceutical Products: Main Principles'', WHO Technical Report Series. The general framework against which a GMP claim is assessed.</ref> | 83 | <ref name="gmp">World Health Organization, ''Good Manufacturing Practices for Pharmaceutical Products: Main Principles'', WHO Technical Report Series. The general framework against which a GMP claim is assessed.</ref> |