Beyond-use date: difference between revisions
Diff·revision 36 → 37·18:54, 4 May 2025
Difference between revision 36 and revision 37 of Beyond-use date. 2 lines changed; the page grew by 541 bytes.
| Revision 36 — 11:06, 26 Apr 2025 Compounding_Cate (talk) split section 13,131 bytes ±0 | Revision 37 — 18:54, 4 May 2025 UnitsUrsula (talk) copyedit 13,672 bytes +541 | ||
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| 93 | The 28-day figure derives from the antimicrobial effectiveness testing in USP <51>, whose challenge protocol runs over 28 days, together with infection-control practice. It is not a chemical stability figure and was never derived as one, a point on which this wiki has had to correct several articles.{{r|usp51,ppbud}} | 93 | The 28-day figure derives from the antimicrobial effectiveness testing in USP <51>, whose challenge protocol runs over 28 days, together with infection-control practice. It is not a chemical stability figure and was never derived as one, a point on which this wiki has had to correct several articles.{{r|usp51,ppbud}} |
| 94 | 94 | ||
| + | 95 | Reconstitution of a lyophilised product is the case most relevant to this wiki. Where the manufacturer has established a period for the reconstituted product, that period appears in the labelling and governs. Where no such period exists — the situation for essentially all peptides distributed for research use — no compendial default is directly applicable either, because the default tables in <797> govern preparations compounded under the chapter's conditions and not preparations made outside any such framework.{{r|usp797,ppbud}} | |
| + | 96 | ||
| 95 | == References == | 97 | == References == |
| 96 | {{reflist}} | 98 | {{reflist}} |