Sterile water for injection: difference between revisions
Diff·revision 4 → 5·09:48, 24 Sep 2024
Difference between revision 4 and revision 5 of Sterile water for injection. 2 lines changed; the page grew by 216 bytes.
| Revision 4 — 07:05, 5 Sep 2024 SyringeSybille (talk) correct the label on the second column — that is volume, not mass 1,810 bytes ±0 | Revision 5 — 09:48, 24 Sep 2024 BetaCellBoyd (talk) state the number of doses a vial yields at that concentration 2,026 bytes +216 | ||
|---|---|---|---|
| 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 | It is also hypotonic. Water alone is not isotonic with tissue, so a preparation reconstituted in it is hypotonic unless the solute makes it otherwise, which for a few milligrams of peptide it does not.{{r|usp_wfi}} | |
| + | 13 | ||
| 12 | == Compendial requirements == | 14 | == 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}} | 15 | 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}} |