Beyond-use date: difference between revisions
Diff·revision 21 → 22·05:31, 16 Jan 2025
Difference between revision 21 and revision 22 of Beyond-use date. 9 lines changed; the page grew by 492 bytes.
| Revision 21 — 03:14, 9 Jan 2025 Retention_Time_Rae (talk) consistent en dashes in ranges 8,395 bytes +646 | Revision 22 — 05:31, 16 Jan 2025 NurseNoteNessa (talk) rv — see talk 8,887 bytes +492 | ||
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| 59 | Three structural features of the table repay attention. Sterility testing buys a large extension — from 4 days to 30 at room temperature for an aseptically processed preparation from sterile components — which reflects that the untested default is a bound on the probability of undetected contamination rather than an estimate of when contamination occurs. Introducing a nonsterile starting component shortens the dating sharply, because the bioburden and endotoxin history of that component is unknown. And frozen storage flattens the differences, because microbial growth is suppressed and the residual limit becomes chemical.{{r|usp797}} | 59 | Three structural features of the table repay attention. Sterility testing buys a large extension — from 4 days to 30 at room temperature for an aseptically processed preparation from sterile components — which reflects that the untested default is a bound on the probability of undetected contamination rather than an estimate of when contamination occurs. Introducing a nonsterile starting component shortens the dating sharply, because the bioburden and endotoxin history of that component is unknown. And frozen storage flattens the differences, because microbial growth is suppressed and the residual limit becomes chemical.{{r|usp797}} |
| 60 | 60 | ||
| + | 61 | == Nonsterile preparations under USP <795> == | |
| + | 62 | Nonsterile compounded preparations are dated under USP <795>, which in its 2023 revision assigns defaults by dosage form and water activity rather than by a calculation from component expiry. | |
| + | 63 | ||
| + | 64 | | Preparation type | Default beyond-use date | | |
| + | 65 | |---|---| | |
| + | 66 | | Nonaqueous dosage forms | 180 days | | |
| + | 67 | | Water-containing oral formulations | 14 days, refrigerated | | |
| + | 68 | | Water-containing topical, dermal and mucosal liquid and semisolid formulations | 30 days | | |
| + | 69 | ||
| 61 | == References == | 70 | == References == |
| 62 | {{reflist}} | 71 | {{reflist}} |