USP General Chapter 85: difference between revisions
Diff·revision 17 → 18·22:35, 13 Aug 2025
Difference between revision 17 and revision 18 of USP General Chapter 85. 5 lines changed; the page grew by 625 bytes.
| Revision 17 — 11:51, 15 Jul 2025 ArchiveBot (talk) bot: repair redlinked category 4,295 bytes ±0 | Revision 18 — 22:35, 13 Aug 2025 AnalyticalAnnie (talk) clarify that mass spectrometry confirms identity, not purity 4,920 bytes +625 | ||
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| 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}} | 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 | 34 | ||
| + | 35 | == Applicability to research material == | |
| + | 36 | Compendial chapters apply to articles for which a monograph or a regulatory requirement invokes them. Research-chemical peptides are not such articles, so [[Bacterial endotoxin test|endotoxin]] determination on them is voluntary and the compendial limits do not formally apply.{{r|usp_general}} | |
| + | 37 | ||
| + | 38 | Citing the chapter on such a certificate is nonetheless meaningful in a narrower sense: it says the method followed a published procedure rather than an internal one, which makes it comparable with other determinations. That is a statement about method provenance, not about compliance. | |
| + | 39 | ||
| 35 | == References == | 40 | == References == |
| 36 | {{reflist}} | 41 | {{reflist}} |