Sterile water for injection: difference between revisions
Diff·revision 5 → 6·01:25, 5 Oct 2024
Difference between revision 5 and revision 6 of Sterile water for injection. 4 lines changed; the page grew by 393 bytes.
| Revision 5 — 09:48, 24 Sep 2024 BetaCellBoyd (talk) state the number of doses a vial yields at that concentration 2,026 bytes +216 | Revision 6 — 01:25, 5 Oct 2024 DeadSpaceDot (talk) expand §Compendial requirements 2,419 bytes +393 | ||
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| 17 | Sterility of the water is not the same as sterility of the preparation made from it. A non-sterile powder reconstituted in sterile water yields a non-sterile solution, and the water's compendial status does not transfer. See [[Sterility testing]]. | 17 | Sterility of the water is not the same as sterility of the preparation made from it. A non-sterile powder reconstituted in sterile water yields a non-sterile solution, and the water's compendial status does not transfer. See [[Sterility testing]]. |
| 18 | 18 | ||
| + | 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 | ||
| 19 | == References == | 21 | == References == |
| 20 | {{reflist}} | 22 | {{reflist}} |
| 21 | <ref name="usp_wfi">United States Pharmacopeia, monograph ''Sterile Water for Injection'', and General Chapter <1231>, ''Water for Pharmaceutical Purposes''.</ref> | 23 | <ref name="usp_wfi">United States Pharmacopeia, monograph ''Sterile Water for Injection'', and General Chapter <1231>, ''Water for Pharmaceutical Purposes''.</ref> |
| 22 | <ref name="usp797">United States Pharmacopeia, General Chapter <797>, ''Pharmaceutical Compounding — Sterile Preparations''.</ref> | 24 | <ref name="usp797">United States Pharmacopeia, General Chapter <797>, ''Pharmaceutical Compounding — Sterile Preparations''.</ref> |
| + | 25 | <ref name="usp85">United States Pharmacopeia, General Chapter <85>, ''Bacterial Endotoxins Test''.</ref> | |
| 23 | 26 | ||
| 24 | {{DEFAULTSORT:Sterile water for injection}} | 27 | {{DEFAULTSORT:Sterile water for injection}} |
| 25 | [[Category:Preparation and handling]] | 28 | [[Category:Preparation and handling]] |
| 26 | [[Category:Clinical practice]] | 29 | [[Category:Clinical practice]] |
| + | 30 | [[Category:Compendial testing]] | |
| 27 | 31 |