Sterile water for injection: difference between revisions
Diff·revision 15 → 16·06:28, 5 May 2025
Difference between revision 15 and revision 16 of Sterile water for injection. 7 lines changed; the page grew by 794 bytes.
| Revision 15 — 03:31, 11 Apr 2025 AnalyticalAnnie (talk) add the dead-space volume to the worked example 3,619 bytes ±0 | Revision 16 — 06:28, 5 May 2025 SurvodutideSaff (talk) expand §Compendial requirements 4,413 bytes +794 | ||
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| 27 | For research peptides, compatibility with benzyl alcohol is generally uncharacterised, so neither choice can be justified on compatibility grounds from published data. That is a statement about the evidence rather than a recommendation.{{r|usp1503}} | 27 | For research peptides, compatibility with benzyl alcohol is generally uncharacterised, so neither choice can be justified on compatibility grounds from published data. That is a statement about the evidence rather than a recommendation.{{r|usp1503}} |
| 28 | 28 | ||
| + | 29 | == What it does not provide == | |
| + | 30 | Sterile water is not a buffer. Peptide solubility and stability are pH-dependent, and a peptide dissolved in unbuffered water sits at whatever pH its own ionisable groups and any residual acid produce — which for a [[Trifluoroacetate counterion|trifluoroacetate salt]] is acidic.{{r|manning2010}} | |
| + | 31 | ||
| + | 32 | It is not a preservative, a stabiliser, or a treatment for a degraded material. A cake that has changed appearance will dissolve in it just as readily as one that has not, and the resulting clarity says nothing about chemical integrity. | |
| + | 33 | ||
| 29 | == References == | 34 | == References == |
| 30 | {{reflist}} | 35 | {{reflist}} |
| ⋮ | ⋮ | ||
| 32 | <ref name="usp797">United States Pharmacopeia, General Chapter <797>, ''Pharmaceutical Compounding — Sterile Preparations''.</ref> | 37 | <ref name="usp797">United States Pharmacopeia, General Chapter <797>, ''Pharmaceutical Compounding — Sterile Preparations''.</ref> |
| 33 | <ref name="usp85">United States Pharmacopeia, General Chapter <85>, ''Bacterial Endotoxins Test''.</ref> | 38 | <ref name="usp85">United States Pharmacopeia, General Chapter <85>, ''Bacterial Endotoxins Test''.</ref> |
| + | 39 | <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> | |
| 34 | <ref name="usp1503">United States Pharmacopeia, General Chapter <1503>, ''Quality Attributes of Synthetic Peptide Drug Substances''.</ref> | 40 | <ref name="usp1503">United States Pharmacopeia, General Chapter <1503>, ''Quality Attributes of Synthetic Peptide Drug Substances''.</ref> |
| 35 | 41 | ||
| ⋮ | ⋮ | ||
| 39 | * [[Sterility testing]] | 45 | * [[Sterility testing]] |
| 40 | * [[Bacterial endotoxin test]] | 46 | * [[Bacterial endotoxin test]] |
| + | 47 | * [[Beyond-use date]] | |
| 41 | 48 | ||
| 42 | {{DEFAULTSORT:Sterile water for injection}} | 49 | {{DEFAULTSORT:Sterile water for injection}} |