Multi-dose vial: difference between revisions
Diff·revision 40 → 41·21:54, 2 Oct 2025
Difference between revision 40 and revision 41 of Multi-dose vial. 2 lines changed; the page grew by 574 bytes.
| Revision 40 — 18:34, 23 Sep 2025 CoI_Corin (talk) expand §The period after initial puncture 20,911 bytes +24 | Revision 41 — 21:54, 2 Oct 2025 BacWaterBarnaby (talk) ce per MOS 21,485 bytes +574 | ||
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| 117 | A vial reconstituted with [[Bacteriostatic water|bacteriostatic water for injection]] contains benzyl alcohol, conventionally at 0.9% w/v. It therefore has the composition of a preserved preparation, but not the demonstration that the preservative is effective ''in that formulation'' — the antimicrobial effectiveness test in USP <51> is performed on a specific finished formulation, and adding a preserved diluent to an arbitrary lyophilised solid does not transfer the demonstration. Whether the resulting solution meets the criteria depends on its pH, on excipients present, on the concentration achieved after dilution by the solid, and on any interaction with the peptide.{{r|usp51,ppmdv}} | 117 | A vial reconstituted with [[Bacteriostatic water|bacteriostatic water for injection]] contains benzyl alcohol, conventionally at 0.9% w/v. It therefore has the composition of a preserved preparation, but not the demonstration that the preservative is effective ''in that formulation'' — the antimicrobial effectiveness test in USP <51> is performed on a specific finished formulation, and adding a preserved diluent to an arbitrary lyophilised solid does not transfer the demonstration. Whether the resulting solution meets the criteria depends on its pH, on excipients present, on the concentration achieved after dilution by the solid, and on any interaction with the peptide.{{r|usp51,ppmdv}} |
| 118 | 118 | ||
| + | 119 | 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}} | |
| + | 120 | ||
| 119 | == References == | 121 | == References == |
| 120 | {{reflist}} | 122 | {{reflist}} |