Beyond-use date: difference between revisions
Diff·revision 9 → 10·09:45, 13 Jan 2025
Difference between revision 9 and revision 10 of Beyond-use date. 11 lines changed; the page grew by 1,138 bytes.
| Revision 9 — 22:14, 26 Dec 2024 UnitAuditUwe (talk) British spelling per PP:MOS 7,749 bytes +218 | Revision 10 — 09:45, 13 Jan 2025 LyophilLena (talk) space between number and unit per PP:MOS 8,887 bytes +1,138 | ||
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| 57 | Periods are those tabulated in the 2023 revision of the chapter, which differs from earlier revisions; the earlier low-, medium- and high-risk classification has been replaced by the category scheme.{{r|usp797}} | 57 | Periods are those tabulated in the 2023 revision of the chapter, which differs from earlier revisions; the earlier low-, medium- and high-risk classification has been replaced by the category scheme.{{r|usp797}} |
| 58 | 58 | ||
| + | 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 | ||
| + | 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 | ||
| 59 | == References == | 70 | == References == |
| 60 | {{reflist}} | 71 | {{reflist}} |