USP General Chapter 71: difference between revisions
Diff·revision 18 → 19·22:59, 26 Aug 2025
Difference between revision 18 and revision 19 of USP General Chapter 71. 3 lines changed; the page grew by 587 bytes.
| Revision 18 — 12:23, 7 Aug 2025 ResolutionRoo (talk) add the sample preparation, since the result depends on it 4,070 bytes ±0 | Revision 19 — 22:59, 26 Aug 2025 UnitAuditUwe (talk) rm the assertion that two laboratories must agree; they need not 4,657 bytes +587 | ||
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| 33 | Where a sterility claim appears, the same distinction applies as for the endotoxin chapter: "tested by the method of USP <71>" is a claim about method provenance, while conformity to a sterility requirement is a claim about regulatory status that a research chemical does not have. | 33 | Where a sterility claim appears, the same distinction applies as for the endotoxin chapter: "tested by the method of USP <71>" is a claim about method provenance, while conformity to a sterility requirement is a claim about regulatory status that a research chemical does not have. |
| 34 | 34 | ||
| + | 35 | The practical position is that such material should be regarded as non-sterile. Related handling considerations are treated at [[Reconstitution of lyophilised peptides]], [[Bacteriostatic water]] and [[Beyond-use date]], and the compounding chapter sets out the practice expected where sterile preparations are genuinely made.{{r|usp797}} Nothing here is medical advice and research-use compounds are not approved for human administration.{{r|usp1503}} | |
| + | 36 | ||
| 35 | == References == | 37 | == References == |
| 36 | {{reflist}} | 38 | {{reflist}} |
| ⋮ | ⋮ | ||
| 38 | <ref name="usp1211">United States Pharmacopeia, General Chapter <1211>, ''Sterility Assurance''.</ref> | 40 | <ref name="usp1211">United States Pharmacopeia, General Chapter <1211>, ''Sterility Assurance''.</ref> |
| 39 | <ref name="usp1503">United States Pharmacopeia, General Chapter <1503>, ''Quality Attributes of Synthetic Peptide Drug Substances''.</ref> | 41 | <ref name="usp1503">United States Pharmacopeia, General Chapter <1503>, ''Quality Attributes of Synthetic Peptide Drug Substances''.</ref> |
| + | 42 | <ref name="usp797">United States Pharmacopeia, General Chapter <797>, ''Pharmaceutical Compounding — Sterile Preparations''.</ref> | |
| 40 | 43 | ||
| 41 | == See also == | 44 | == See also == |