USP General Chapter 85: difference between revisions
Diff·revision 11 → 12·23:36, 25 Mar 2025
Difference between revision 11 and revision 12 of USP General Chapter 85. 4 lines changed; the page grew by 689 bytes.
| Revision 11 — 15:12, 6 Mar 2025 LOD_Lorcan (talk) add the reference standard and its traceability 3,581 bytes +130 | Revision 12 — 23:36, 25 Mar 2025 TitrationTheo (talk) add the repeatability figure with the number of injections 4,270 bytes +689 | ||
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| 31 | | Basis of normalisation | Per mg of what — substance, or vial contents? | | 31 | | Basis of normalisation | Per mg of what — substance, or vial contents? | |
| 32 | 32 | ||
| + | 33 | A numeric result reported from a gel-clot determination is a category error, since the gel-clot method reports whether a clot formed at a dilution rather than a concentration. Certificates showing a number attributed to a gel-clot method are internally inconsistent — see [[Test report forgery]] for the general treatment of internal consistency.{{r|usp1503}} Where a non-endotoxin pyrogen is at issue, a different chapter applies entirely.{{r|usp151}} | |
| + | 34 | ||
| 33 | == References == | 35 | == References == |
| 34 | {{reflist}} | 36 | {{reflist}} |
| 35 | <ref name="usp85">United States Pharmacopeia, General Chapter <85>, ''Bacterial Endotoxins Test''.</ref> | 37 | <ref name="usp85">United States Pharmacopeia, General Chapter <85>, ''Bacterial Endotoxins Test''.</ref> |
| 36 | <ref name="usp_general">United States Pharmacopeia, ''General Notices and Requirements'', section 3 (conformance to standards) and the numbering convention for general chapters.</ref> | 38 | <ref name="usp_general">United States Pharmacopeia, ''General Notices and Requirements'', section 3 (conformance to standards) and the numbering convention for general chapters.</ref> |
| + | 39 | <ref name="usp1503">United States Pharmacopeia, General Chapter <1503>, ''Quality Attributes of Synthetic Peptide Drug Substances''.</ref> | |
| + | 40 | <ref name="usp151">United States Pharmacopeia, General Chapter <151>, ''Pyrogen Test''.</ref> | |
| 37 | 41 | ||
| 38 | == See also == | 42 | == See also == |