Beyond-use date: difference between revisions
Diff·revision 40 → 41·01:08, 6 Jun 2025
Difference between revision 40 and revision 41 of Beyond-use date. 7 lines changed; the page grew by 1,045 bytes.
| Revision 40 — 11:49, 28 May 2025 UnitAuditUwe (talk) clarify whether figure is gross or net mass 13,672 bytes ±0 | Revision 41 — 01:08, 6 Jun 2025 Chromatokid (talk) add see also 14,717 bytes +1,045 | ||
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| 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}} | 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 | 96 | ||
| + | 97 | == Assignment in the absence of data == | |
| + | 98 | Where a preparation-specific stability study is unavailable — the usual case — the compendial approach is to apply a conservative default and to shorten it where any consideration suggests it should be shorter. The considerations enumerated in <795> and <1191> include the nature of the active substance and its degradation mechanism, the container and its potential for sorption or permeation, the storage condition, the expected duration of use, and the presence of water.{{r|usp795,usp1191}} | |
| + | 99 | ||
| + | 100 | Date arithmetic is simple and worth stating explicitly, because errors in it are common and consequential. | |
| + | 101 | ||
| + | 102 | A lyophilised vial is reconstituted on 12 March and stored refrigerated. A 28-day period gives a beyond-use date of 9 April: the count runs from the day of preparation, and the beyond-use date is the last day on which the preparation may be used, not the first on which it may not — a convention on which sources differ, so that a stated date without a stated convention is ambiguous by a day. | |
| + | 103 | ||
| 97 | == References == | 104 | == References == |
| 98 | {{reflist}} | 105 | {{reflist}} |