Beyond-use date: difference between revisions
Diff·revision 32 → 33·06:41, 2 Apr 2025
Difference between revision 32 and revision 33 of Beyond-use date. 3 lines changed; the page grew by 559 bytes.
| Revision 32 — 23:44, 25 Mar 2025 Chromatokid (talk) rm maintenance tag, addressed 12,555 bytes +461 | Revision 33 — 06:41, 2 Apr 2025 CiteBot (talk) bot: repair redlinked category 13,114 bytes +559 | ||
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| 21 | {{hatnote|Not to be confused with the manufacturer expiration date, which is established by a formal stability programme under ICH Q1A(R2).}} | 21 | {{hatnote|Not to be confused with the manufacturer expiration date, which is established by a formal stability programme under ICH Q1A(R2).}} |
| + | 22 | {{accuracy|date=February 2026|talk=RfC: conflation of beyond-use date and expiration date}} | |
| 22 | 23 | ||
| 23 | A '''beyond-use date''' ('''BUD''') is the date, or date and time, after which a compounded preparation or an opened container is not to be used. It is assigned by the person who prepares or opens the preparation, using compendial default tables or, where available, testing specific to the preparation. It is distinct from an '''expiration date''', which is assigned by a manufacturer on the basis of a formal stability programme conducted on the finished product in its final container.{{r|usp797,usp1191}} | 24 | A '''beyond-use date''' ('''BUD''') is the date, or date and time, after which a compounded preparation or an opened container is not to be used. It is assigned by the person who prepares or opens the preparation, using compendial default tables or, where available, testing specific to the preparation. It is distinct from an '''expiration date''', which is assigned by a manufacturer on the basis of a formal stability programme conducted on the finished product in its final container.{{r|usp797,usp1191}} |
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| 81 | The 2023 chapter also permits longer dating where supported by a stability-indicating study on the preparation, or by published stability information for the same formulation in the same container and storage condition. The qualification about container and condition is not incidental: published stability data for a solution in a glass vial does not transfer to the same solution in a plastic syringe, because sorption and permeation differ.{{r|usp795,trissel2022}} | 82 | The 2023 chapter also permits longer dating where supported by a stability-indicating study on the preparation, or by published stability information for the same formulation in the same container and storage condition. The qualification about container and condition is not incidental: published stability data for a solution in a glass vial does not transfer to the same solution in a plastic syringe, because sorption and permeation differ.{{r|usp795,trissel2022}} |
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| + | 84 | Water activity is the organising principle behind the dosage-form distinctions. Preparations in which water is available support microbial growth and hydrolytic degradation; those in which it is not, or is bound, support neither to the same degree. This is the same principle that makes a lyophilised solid far more stable than its reconstituted solution, and it connects the compendial framework to the physical chemistry set out at [[Lyophilisation]].{{r|usp795}} | |
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| 83 | == Opened containers == | 86 | == Opened containers == |