Beyond-use date: difference between revisions
Diff·revision 49 → 50·04:45, 25 Aug 2025
Difference between revision 49 and revision 50 of Beyond-use date. 9 lines changed; the page grew by 711 bytes.
| Revision 49 — 18:16, 13 Aug 2025 RotationRosalind (talk) fix category — parent was wrong 18,154 bytes +989 | Revision 50 — 04:45, 25 Aug 2025 SigFigSindri (talk) restructure 18,865 bytes +711 | ||
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| 115 | For material distributed outside regulated channels, third-party purity testing of a reconstituted solution after storage is occasionally reported and is a genuine improvement on assertion. Without a matched baseline result on the same lot before storage, however, it cannot distinguish degradation during storage from a purity deficit present at manufacture — the same limitation described at [[Temperature excursion]].{{r|ppbud}} | 115 | For material distributed outside regulated channels, third-party purity testing of a reconstituted solution after storage is occasionally reported and is a genuine improvement on assertion. Without a matched baseline result on the same lot before storage, however, it cannot distinguish degradation during storage from a purity deficit present at manufacture — the same limitation described at [[Temperature excursion]].{{r|ppbud}} |
| 116 | 116 | ||
| + | 117 | == Labelling and records == | |
| + | 118 | A beyond-use date exists only as a record, which makes labelling part of the standard rather than an administrative addition. USP <797> requires that a compounded sterile preparation be labelled with, among other items, the assigned beyond-use date and the storage condition to which it applies, because the date is conditional on that condition and is meaningless without it.{{r|usp797}} | |
| + | 119 | ||
| + | 120 | Three items make a beyond-use date interpretable, and the omission of any one makes it uninterpretable: | |
| + | 121 | ||
| + | 122 | * the date, with the convention stated or evident; | |
| + | 123 | * the storage condition assumed; | |
| + | 124 | * what the preparation is, at what concentration, in enough detail to identify the applicable default. | |
| + | 125 | ||
| 117 | == References == | 126 | == References == |
| 118 | {{reflist}} | 127 | {{reflist}} |