Multi-dose vial: difference between revisions
Diff·revision 19 → 20·13:53, 6 Nov 2025
Difference between revision 19 and revision 20 of Multi-dose vial. 5 lines changed; the page grew by 847 bytes.
| Revision 19 — 15:57, 15 Oct 2025 Chromatokid (talk) the rounding in the table lost a decimal place that matters at low doses 21,761 bytes +276 | Revision 20 — 13:53, 6 Nov 2025 StabilityStig (talk) give the worked example to two significant figures throughout 22,608 bytes +847 | ||
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| 121 | Two further considerations arise specifically in this context. The diluent volume chosen determines the final benzyl alcohol concentration only if the solid contributes negligible volume, which is the usual case for a few milligrams of peptide but not for a formulated product with a bulking agent. And the number of withdrawals is typically far higher than for a manufactured multiple-dose product — a vial divided into ten or twenty doses is common — which multiplies both the coring probability and the number of disinfection and technique opportunities.{{r|ppmdv}} | 121 | Two further considerations arise specifically in this context. The diluent volume chosen determines the final benzyl alcohol concentration only if the solid contributes negligible volume, which is the usual case for a few milligrams of peptide but not for a formulated product with a bulking agent. And the number of withdrawals is typically far higher than for a manufactured multiple-dose product — a vial divided into ten or twenty doses is common — which multiplies both the coring probability and the number of disinfection and technique opportunities.{{r|ppmdv}} |
| 122 | 122 | ||
| + | 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 | ||
| 123 | == References == | 125 | == References == |
| 124 | {{reflist}} | 126 | {{reflist}} |
| ⋮ | ⋮ | ||
| 140 | * Dolan SA, Felizardo G, Barnes S, et al. "APIC position paper: safe injection, infusion, and medication vial practices in health care." ''American Journal of Infection Control'' 38(3):167–172 (2010). | 142 | * Dolan SA, Felizardo G, Barnes S, et al. "APIC position paper: safe injection, infusion, and medication vial practices in health care." ''American Journal of Infection Control'' 38(3):167–172 (2010). |
| 141 | * Meyer BK, Ni A, Hu B, Shi L. "Antimicrobial preservative use in parenteral products: past and present." ''Journal of Pharmaceutical Sciences'' 96(12):3155–3167 (2007). | 143 | * Meyer BK, Ni A, Hu B, Shi L. "Antimicrobial preservative use in parenteral products: past and present." ''Journal of Pharmaceutical Sciences'' 96(12):3155–3167 (2007). |
| + | 144 | ||
| + | 145 | == External links == | |
| + | 146 | * [https://www.usp.org/chemical-medicines/general-chapter-797 USP General Chapter <797> — compounded sterile preparations] — Compendial treatment of single- and multi-dose container practice. | |
| 142 | 147 | ||
| 143 | == See also == | 148 | == See also == |