Multi-dose vial: difference between revisions
Diff·revision 3 → 4·01:52, 16 Feb 2025
Difference between revision 3 and revision 4 of Multi-dose vial. 9 lines changed; the page grew by 1,505 bytes.
| Revision 3 — 18:02, 11 Feb 2025 DrTitration (talk) correct the label on the second column — that is volume, not mass 2,861 bytes +784 | Revision 4 — 01:52, 16 Feb 2025 DrTitration (talk) expand §Reconstituted peptides and multiple withdrawal 4,366 bytes +1,505 | ||
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| 13 | The 28-day convention is frequently misread as a statement about chemical stability. It is not: it derives from the antimicrobial effectiveness of preserved formulations and from infection-control practice, and it is independent of whether the active substance remains within specification. A preparation may be chemically stable for a year and still be discarded at 28 days, and a preparation may lose potency well before 28 days despite its preservative performing perfectly.{{r|usp797,cdc_injection}} | 13 | The 28-day convention is frequently misread as a statement about chemical stability. It is not: it derives from the antimicrobial effectiveness of preserved formulations and from infection-control practice, and it is independent of whether the active substance remains within specification. A preparation may be chemically stable for a year and still be discarded at 28 days, and a preparation may lose potency well before 28 days despite its preservative performing perfectly.{{r|usp797,cdc_injection}} |
| 14 | 14 | ||
| + | 15 | == Definition and compendial basis == | |
| + | 16 | USP <659> distinguishes several container categories, and the distinctions govern labelling and use. | |
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| + | 18 | ; Single-dose container : A single-unit container for an article intended for parenteral administration only, used once and discarded. Ampoules and prefilled syringes are inherently single-dose; a vial is single-dose if so labelled. | |
| + | 19 | ; Multiple-dose container : A multiple-unit container for an article intended for parenteral administration only, permitting withdrawal of successive portions without altering the remainder. | |
| + | 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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| 15 | == References == | 24 | == References == |
| 16 | {{reflist}} | 25 | {{reflist}} |