Multi-dose vial: difference between revisions
Diff·revision 8 → 9·03:50, 21 Feb 2025
Difference between revision 8 and revision 9 of Multi-dose vial. 2 lines changed; the page grew by 602 bytes.
| Revision 8 — 00:28, 19 Feb 2025 KarlFischerKit (talk) remove weasel wording 3,764 bytes ±0 | Revision 9 — 03:50, 21 Feb 2025 MelanocortinMil (talk) add table 4,366 bytes +602 | ||
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| 20 | ; Pharmacy bulk package : A container of a sterile preparation for parenteral use containing many single doses, intended for further dilution or dispensing in a suitable environment, and not for direct administration. Its permitted period after entry is short — commonly stated on the label and typically measured in hours.{{r|usp659}} | 20 | ; Pharmacy bulk package : A container of a sterile preparation for parenteral use containing many single doses, intended for further dilution or dispensing in a suitable environment, and not for direct administration. Its permitted period after entry is short — commonly stated on the label and typically measured in hours.{{r|usp659}} |
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| + | 22 | The requirement for a preservative in a multiple-dose container appears in the general requirements for injections, and the demonstration of effectiveness is by the antimicrobial effectiveness test in USP <51>. That test challenges the formulation with specified organisms — ''Staphylococcus aureus'', ''Pseudomonas aeruginosa'', ''Escherichia coli'', ''Candida albicans'' and ''Aspergillus brasiliensis'' — and requires defined log reductions at defined intervals over 28 days. For injectable products the criteria are the most demanding of the product categories the chapter defines.{{r|usp51}} | |
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| 22 | == References == | 24 | == References == |
| 23 | {{reflist}} | 25 | {{reflist}} |