Research use only: difference between revisions
Diff·revision 12 → 13·15:02, 24 Nov 2024
Difference between revision 12 and revision 13 of Research use only. 5 lines changed; the page grew by 996 bytes.
| Revision 12 — 14:43, 10 Nov 2024 API_Aurora (talk) clarify that a business licence is not a manufacturing authorisation 3,726 bytes ±0 | Revision 13 — 15:02, 24 Nov 2024 SelectTrialSam (talk) add the jurisdiction to the legal statement 4,722 bytes +996 | ||
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| 8 | | Assessed by = No authority | 8 | | Assessed by = No authority |
| 9 | }} | 9 | }} |
| + | 10 | {{hatnote|This article describes a labelling category and the legal position around it. It is not legal advice, and nothing on this wiki is medical advice — see [[Project:Medical disclaimer]].}} | |
| 10 | 11 | ||
| 11 | '''Research use only''' is a label applied by a seller to material offered for laboratory work rather than for administration to humans or animals. The phrase, and its abbreviation RUO, appears on the great majority of research-peptide listings, invoices and [[Certificate of analysis|certificates]].{{r|ruo}} | 12 | '''Research use only''' is a label applied by a seller to material offered for laboratory work rather than for administration to humans or animals. The phrase, and its abbreviation RUO, appears on the great majority of research-peptide listings, invoices and [[Certificate of analysis|certificates]].{{r|ruo}} |
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| 27 | {{warn|Material described anywhere on this wiki as research-use-only is not approved for human use. PeptidePedia describes what is documented about such material; it does not advise on its use, and nothing here is medical advice.}} | 28 | {{warn|Material described anywhere on this wiki as research-use-only is not approved for human use. PeptidePedia describes what is documented about such material; it does not advise on its use, and nothing here is medical advice.}} |
| 28 | 29 | ||
| + | 30 | == What a business registration does and does not establish == | |
| + | 31 | A frequent inference runs: the supplier is a registered company, therefore its material is regulated. It does not follow. A business registration is a licensing fact — it establishes that an entity exists, has a registered address, and has declared a scope of business.{{r|registry}} It says nothing about quality systems, and a declared business scope that includes chemical manufacture is a permission to trade rather than an assurance about output. | |
| + | 32 | ||
| 29 | == References == | 33 | == References == |
| 30 | {{reflist}} | 34 | {{reflist}} |
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| 32 | <ref name="gmp">World Health Organization, ''Good Manufacturing Practices for Pharmaceutical Products: Main Principles'', WHO Technical Report Series. The general framework against which a quality-system claim would be assessed.</ref> | 36 | <ref name="gmp">World Health Organization, ''Good Manufacturing Practices for Pharmaceutical Products: Main Principles'', WHO Technical Report Series. The general framework against which a quality-system claim would be assessed.</ref> |
| 33 | <ref name="usp1503">United States Pharmacopeia, General Chapter <1503>, "Quality Attributes of Synthetic Peptide Drug Substances" (informational). USP–NF, current revision.</ref> | 37 | <ref name="usp1503">United States Pharmacopeia, General Chapter <1503>, "Quality Attributes of Synthetic Peptide Drug Substances" (informational). USP–NF, current revision.</ref> |
| + | 38 | <ref name="registry">National Enterprise Credit Information Publicity System (国家企业信用信息公示系统), company registration records, retrieved 2026. Registry records establish existence, address and declared scope of business; they are not a quality assurance.</ref> | |
| 34 | 39 | ||
| 35 | {{DEFAULTSORT:Research use only}} | 40 | {{DEFAULTSORT:Research use only}} |