Sterile water for injection: difference between revisions
Diff·revision 8 → 9·18:37, 25 Nov 2024
Difference between revision 8 and revision 9 of Sterile water for injection. 5 lines changed; the page grew by 643 bytes.
| Revision 8 — 17:49, 4 Nov 2024 MassSpecMarv (talk) add the disclaimer that this is not administration guidance 2,419 bytes ±0 | Revision 9 — 18:37, 25 Nov 2024 OralSemaOswin (talk) add the diluent volume the example assumes 3,062 bytes +643 | ||
|---|---|---|---|
| 19 | Endotoxin limits apply to the water because [[Bacterial endotoxin test|endotoxin]] survives sterilisation. Water systems are the classic source of endotoxin contamination, and controlling them is a manufacturing rather than a testing exercise.{{r|usp85}} | 19 | Endotoxin limits apply to the water because [[Bacterial endotoxin test|endotoxin]] survives sterilisation. Water systems are the classic source of endotoxin contamination, and controlling them is a manufacturing rather than a testing exercise.{{r|usp85}} |
| 20 | 20 | ||
| + | 21 | == When it is used rather than a preserved diluent == | |
| + | 22 | Unpreserved water is used where the preparation is for immediate single use, where the active substance is incompatible with the preservative, or where the preservative is contraindicated in the intended recipient.{{r|usp797}} | |
| + | 23 | ||
| + | 24 | The trade-off is direct. An unpreserved container must be treated as single-entry, so any material remaining is discarded; a preserved container can be entered repeatedly within its dating. Where a small quantity of active substance is reconstituted into a volume larger than a single withdrawal, that difference determines how much of the material is usable. | |
| + | 25 | ||
| 21 | == References == | 26 | == References == |
| 22 | {{reflist}} | 27 | {{reflist}} |