Beyond-use date: difference between revisions
Diff·revision 12 → 13·13:39, 25 Nov 2024
Difference between revision 12 and revision 13 of Beyond-use date. 14 lines changed; the page grew by 1,252 bytes.
| Revision 12 — 17:52, 19 Nov 2024 SyringeSybille (talk) clarify whether figure is gross or net mass 4,878 bytes ±0 | Revision 13 — 13:39, 25 Nov 2024 GramsNotUnitsGil (talk) add confidence interval 6,130 bytes +1,252 | ||
|---|---|---|---|
| 30 | Two consequences of the table are worth drawing out. Because the two dates are limited by different things, they respond differently to storage: refrigeration extends a microbiologically limited beyond-use date substantially and generally extends an expiration date not at all, since the expiration date already assumes the labelled condition. And because a beyond-use date is assigned rather than measured, it can be assigned correctly to a preparation that has in fact already degraded, if the degradation route was one the default table does not contemplate.{{r|usp797,usp1191}} | 30 | Two consequences of the table are worth drawing out. Because the two dates are limited by different things, they respond differently to storage: refrigeration extends a microbiologically limited beyond-use date substantially and generally extends an expiration date not at all, since the expiration date already assumes the labelled condition. And because a beyond-use date is assigned rather than measured, it can be assigned correctly to a preparation that has in fact already degraded, if the degradation route was one the default table does not contemplate.{{r|usp797,usp1191}} |
| 31 | 31 | ||
| + | 32 | == Sterile preparations under USP <797> == | |
| + | 33 | USP <797> classifies compounded sterile preparations into categories by the conditions under which they are made, and assigns default beyond-use dates by category, by whether sterility testing was performed, and by storage temperature. | |
| + | 34 | ||
| + | 35 | Category 1 preparations are made in an unclassified segregated compounding area and carry the shortest dating. Category 2 preparations are made in a cleanroom suite meeting the chapter's requirements. Category 3 preparations meet additional requirements — including sterility and endotoxin testing and more extensive personnel qualification — and may carry substantially longer dating. | |
| + | 36 | ||
| + | 37 | |+ Default beyond-use dates for Category 2 preparations, USP <797> 2023 revision | |
| + | 38 | | !Preparation method | Sterility tested and passing | Controlled room temperature | Refrigerated | Frozen | | |
| + | 39 | |---|---|---|---|---| | |
| + | 40 | | Aseptically processed, from sterile components only | No | 4 days | 10 days | 45 days | | |
| + | 41 | | Aseptically processed, one or more nonsterile components | No | 1 day | 4 days | 45 days | | |
| + | 42 | | Aseptically processed | Yes | 30 days | 45 days | 60 days | | |
| + | 43 | | Terminally sterilised | No | 14 days | 28 days | 45 days | | |
| + | 44 | | Terminally sterilised | Yes | 45 days | 60 days | 90 days | | |
| + | 45 | ||
| 32 | == References == | 46 | == References == |
| 33 | {{reflist}} | 47 | {{reflist}} |