Multi-dose vial: difference between revisions
Diff·revision 20 → 21·23:15, 26 Nov 2025
Difference between revision 20 and revision 21 of Multi-dose vial. 2 lines changed; the page grew by 68 bytes.
| Revision 20 — 13:53, 6 Nov 2025 StabilityStig (talk) give the worked example to two significant figures throughout 22,608 bytes +847 | Revision 21 — 23:15, 26 Nov 2025 GastroparesisGwen (talk) expand §Repeated entry: coring and closure integrity 22,676 bytes +68 | ||
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| 123 | Community practice, as collated on this wiki, generally assigns a period of about 28 days to a vial reconstituted with bacteriostatic water and a much shorter period to one reconstituted with unpreserved diluent, and stores both refrigerated. That practice is consistent with the compendial framework in shape, but it rests on an analogy rather than on data for any specific preparation, and no sterility or preservative-effectiveness testing of such preparations has been published. The reports are self-selected and record no adverse outcome, which is a weak endpoint given that the outcome of concern is uncommon.{{r|ppmdv}} | 123 | Community practice, as collated on this wiki, generally assigns a period of about 28 days to a vial reconstituted with bacteriostatic water and a much shorter period to one reconstituted with unpreserved diluent, and stores both refrigerated. That practice is consistent with the compendial framework in shape, but it rests on an analogy rather than on data for any specific preparation, and no sterility or preservative-effectiveness testing of such preparations has been published. The reports are self-selected and record no adverse outcome, which is a weak endpoint given that the outcome of concern is uncommon.{{r|ppmdv}} |
| 124 | 124 | ||
| + | 125 | {{seealso|Beyond-use date|Bacteriostatic water|Sterility testing}} | |
| + | 126 | ||
| 125 | == References == | 127 | == References == |
| 126 | {{reflist}} | 128 | {{reflist}} |