Bacteriostatic water: difference between revisions
Diff·revision 4 → 5·17:52, 13 Aug 2024
Difference between revision 4 and revision 5 of Bacteriostatic water. 3 lines changed; the page grew by 443 bytes.
| Revision 4 — 06:50, 28 Jul 2024 StubSorterBot (talk) bot: repair redlinked category 2,332 bytes +482 | Revision 5 — 17:52, 13 Aug 2024 ArchiveBot (talk) bot: add stub category 2,775 bytes +443 | ||
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| 10 | It is a diluent, not a treatment for non-sterile material. Adding it to a powder that was never sterile produces a non-sterile solution containing a preservative — the preservative retards growth of what is there rather than eliminating it.{{r|usp797}} | 10 | It is a diluent, not a treatment for non-sterile material. Adding it to a powder that was never sterile produces a non-sterile solution containing a preservative — the preservative retards growth of what is there rather than eliminating it.{{r|usp797}} |
| 11 | 11 | ||
| + | 12 | Benzyl alcohol is not inert. It has recognised toxicity at high cumulative exposure, is contraindicated in neonates, and can interact with certain formulations. Where a peptide is known to be preservative-sensitive, an unpreserved diluent is used and the container treated as single-entry.{{r|usp1503}} | |
| + | 13 | ||
| 12 | == What the preservative does == | 14 | == What the preservative does == |
| 13 | Antimicrobial effectiveness is a defined pharmacopoeial property: a preserved preparation is challenged with specified organisms and must reduce their numbers by defined amounts over defined intervals. Benzyl alcohol meets that requirement over the concentration and pH ranges in which it is used.{{r|usp51}} | 15 | Antimicrobial effectiveness is a defined pharmacopoeial property: a preserved preparation is challenged with specified organisms and must reduce their numbers by defined amounts over defined intervals. Benzyl alcohol meets that requirement over the concentration and pH ranges in which it is used.{{r|usp51}} |
| ⋮ | ⋮ | ||
| 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> |
| 23 | <ref name="manning2010">Manning MC, Chou DK, Murphy BM, Payne RW, Katayama DS. "Stability of protein pharmaceuticals: an update." ''Pharmaceutical Research'' 27(4):544–575 (2010). PMID 20143256.</ref> | 25 | <ref name="manning2010">Manning MC, Chou DK, Murphy BM, Payne RW, Katayama DS. "Stability of protein pharmaceuticals: an update." ''Pharmaceutical Research'' 27(4):544–575 (2010). PMID 20143256.</ref> |
| + | 26 | <ref name="usp1503">United States Pharmacopeia, General Chapter <1503>, ''Quality Attributes of Synthetic Peptide Drug Substances''.</ref> | |
| 24 | 27 | ||
| 25 | {{DEFAULTSORT:Bacteriostatic water}} | 28 | {{DEFAULTSORT:Bacteriostatic water}} |