USP General Chapter 85: difference between revisions
Diff·revision 20 → 21·08:04, 28 Oct 2025
Difference between revision 20 and revision 21 of USP General Chapter 85. 2 lines changed; the page grew by 260 bytes.
| Revision 20 — 01:48, 1 Oct 2025 Ref_Desk_Ron (talk) fix indentation in the source 4,920 bytes ±0 | Revision 21 — 08:04, 28 Oct 2025 ReportReaderRilla (talk) rm the claim that the method is stability-indicating without a forced-degradation study 5,180 bytes +260 | ||
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| 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. | 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 | 39 | ||
| + | 40 | The distinction between "tested by the method of USP <85>" and "meets the USP <85> limit for a parenteral product" is substantial, and the two are not always kept apart in supplier documentation. A reader should establish which is being claimed.{{r|usp1503}} | |
| + | 41 | ||
| 40 | == References == | 42 | == References == |
| 41 | {{reflist}} | 43 | {{reflist}} |