Multi-dose vial: difference between revisions
Diff·revision 14 → 15·14:39, 24 Mar 2025
Difference between revision 14 and revision 15 of Multi-dose vial. 3 lines changed; the page grew by 464 bytes.
| Revision 14 — 10:58, 20 Mar 2025 SubQ_Solveig (talk) tag [citation needed] 7,432 bytes ±0 | Revision 15 — 14:39, 24 Mar 2025 StubSorterBot (talk) bot: expand DOI to full citation 7,896 bytes +464 | ||
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| 47 | Concentrations are those conventionally used in marketed injectable products; the effective concentration is formulation-specific and must be demonstrated for the product rather than assumed from the class.{{r|usp51,brange1993}} | 47 | Concentrations are those conventionally used in marketed injectable products; the effective concentration is formulation-specific and must be demonstrated for the product rather than assumed from the class.{{r|usp51,brange1993}} |
| 48 | 48 | ||
| + | 49 | The phenolic preservatives illustrate that a preservative is not an inert additive. In insulin formulations, phenol and m-cresol bind at a specific site on the hexamer and shift the conformational equilibrium, and their presence is required for the physical stability of the formulation as well as for its preservation. Removing the preservative from such a product is therefore not merely a microbiological change.{{r|brange1993}} | |
| + | 50 | ||
| 49 | == References == | 51 | == References == |
| 50 | {{reflist}} | 52 | {{reflist}} |
| ⋮ | ⋮ | ||
| 60 | [[Category:Fill and finish]] | 62 | [[Category:Fill and finish]] |
| 61 | [[Category:Injection technique]] | 63 | [[Category:Injection technique]] |
| + | 64 | [[Category:Clinical practice]] | |
| 62 | 65 |