Sterile water for injection: difference between revisions
Diff·revision 2 → 3·14:27, 26 Aug 2024
Difference between revision 2 and revision 3 of Sterile water for injection. 5 lines changed; the page grew by 585 bytes.
| Revision 2 — 05:58, 20 Aug 2024 Chromatokid (talk) the example withdrew more than the syringe holds; corrected 1,225 bytes ±0 | Revision 3 — 14:27, 26 Aug 2024 CDMO_Caradoc (talk) clarify which volume the graduation marks measure 1,810 bytes +585 | ||
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| 10 | Because it contains no preservative, a container that has been entered offers no barrier to growth of organisms introduced at entry, and it is therefore packaged and used as single-entry. This is the operative difference from [[Bacteriostatic water|bacteriostatic water]].{{r|usp797}} | 10 | Because it contains no preservative, a container that has been entered offers no barrier to growth of organisms introduced at entry, and it is therefore packaged and used as single-entry. This is the operative difference from [[Bacteriostatic water|bacteriostatic water]].{{r|usp797}} |
| 11 | 11 | ||
| + | 12 | == Compendial requirements == | |
| + | 13 | The relevant monograph specifies sterility, freedom from pyrogens, limits on conductivity and total organic carbon, and particulate matter limits. It is prepared by distillation or by a purification process of equivalent capability, and it is not simply purified water in a sealed container.{{r|usp_wfi}} | |
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| + | 15 | 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]]. | |
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| 12 | == References == | 17 | == References == |
| 13 | {{reflist}} | 18 | {{reflist}} |