USP General Chapter 71: difference between revisions
Diff·revision 15 → 16·06:42, 19 Jun 2025
Difference between revision 15 and revision 16 of USP General Chapter 71. 7 lines changed; the page grew by 707 bytes.
| Revision 15 — 14:00, 31 May 2025 ArchiveBot (talk) bot: sort category members 3,363 bytes ±0 | Revision 16 — 06:42, 19 Jun 2025 PeakShapePol (talk) expand §What the chapter specifies 4,070 bytes +707 | ||
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| 28 | For a lyophilised powder, filtration requires dissolution in a suitable diluent, which introduces a step at which contamination can be added or an inhibitory solvent can interfere. The suitability demonstration covers this, which is why it is not optional.{{r|usp1211}} | 28 | For a lyophilised powder, filtration requires dissolution in a suitable diluent, which introduces a step at which contamination can be added or an inhibitory solvent can interfere. The suitability demonstration covers this, which is why it is not optional.{{r|usp1211}} |
| 29 | 29 | ||
| + | 30 | == Applicability to research material == | |
| + | 31 | Research-chemical peptides are not manufactured or released as sterile products, and the chapter does not apply to them. Certificates for such material do not ordinarily carry a sterility determination.{{r|usp1503}} | |
| + | 32 | ||
| + | 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 | ||
| 30 | == References == | 35 | == References == |
| 31 | {{reflist}} | 36 | {{reflist}} |
| 32 | <ref name="usp71">United States Pharmacopeia, General Chapter <71>, ''Sterility Tests''.</ref> | 37 | <ref name="usp71">United States Pharmacopeia, General Chapter <71>, ''Sterility Tests''.</ref> |
| 33 | <ref name="usp1211">United States Pharmacopeia, General Chapter <1211>, ''Sterility Assurance''.</ref> | 38 | <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> | |
| 34 | 40 | ||
| 35 | == See also == | 41 | == See also == |
| ⋮ | ⋮ | ||
| 38 | * [[Bacterial endotoxin test]] | 44 | * [[Bacterial endotoxin test]] |
| 39 | * [[Beyond-use date]] | 45 | * [[Beyond-use date]] |
| + | 46 | * [[Bacteriostatic water]] | |
| 40 | 47 | ||
| 41 | {{DEFAULTSORT:USP General Chapter 71}} | 48 | {{DEFAULTSORT:USP General Chapter 71}} |