Multi-dose vial: difference between revisions
Diff·revision 57 → 58·18:19, 11 Mar 2026
Difference between revision 57 and revision 58 of Multi-dose vial. 2 lines changed; the page grew by 519 bytes.
| Revision 57 — 15:43, 3 Mar 2026 UnitsUrsula (talk) fix significant figures — source gives fewer 24,109 bytes ±0 | Revision 58 — 18:19, 11 Mar 2026 FlowTrialFraser (talk) move table to the section it supports 24,628 bytes +519 | ||
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| 134 | For reconstituted preparations the equivalent record is the reconstitution date, the diluent used and the concentration achieved. None of these is derivable later from the vial: a reconstituted solution offers no visual evidence of its concentration, its diluent or its age. This is the practical reason that the absence of such a record is treated in compounding practice as equivalent to an expired preparation rather than as a documentation lapse.{{r|usp797}} | 134 | For reconstituted preparations the equivalent record is the reconstitution date, the diluent used and the concentration achieved. None of these is derivable later from the vial: a reconstituted solution offers no visual evidence of its concentration, its diluent or its age. This is the practical reason that the absence of such a record is treated in compounding practice as equivalent to an expired preparation rather than as a documentation lapse.{{r|usp797}} |
| 135 | 135 | ||
| + | 136 | Two documentation problems specific to unregulated material are worth recording. Lyophilised vials frequently carry no statement of what is in them beyond a compound name and a nominal mass, so the presence or absence of excipients that would affect a reconstituted preparation's pH or preservative effectiveness is unknown. And where a vial is unlabelled entirely — a practice discussed at [[Vial|vial]] — no in-use record can be attached to the container at all, only to the container's surroundings.{{r|ppmdv}} | |
| + | 137 | ||
| 136 | == References == | 138 | == References == |
| 137 | {{reflist}} | 139 | {{reflist}} |