Bacterial endotoxin test: difference between revisions
Diff·revision 5 → 6·02:41, 11 Oct 2024
Difference between revision 5 and revision 6 of Bacterial endotoxin test. 4 lines changed; the page grew by 505 bytes.
| Revision 5 — 16:18, 27 Sep 2024 KarlFischerKit (talk) add the counterion determination method by name 2,424 bytes +297 | Revision 6 — 02:41, 11 Oct 2024 CiteBot (talk) bot: normalise citation format 2,929 bytes +505 | ||
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| 11 | Endotoxin is not a living organism and is not removed by sterilisation. A preparation can be sterile and pyrogenic at the same time: autoclaving kills bacteria but leaves their lipopolysaccharide intact and biologically active. Endotoxin is the commonest but not the only pyrogen, and a separate rabbit pyrogen test exists for the wider class.{{r|usp151}} This is why endotoxin and [[Sterility testing|sterility]] are separate determinations answering separate questions.{{r|usp85}} | 11 | Endotoxin is not a living organism and is not removed by sterilisation. A preparation can be sterile and pyrogenic at the same time: autoclaving kills bacteria but leaves their lipopolysaccharide intact and biologically active. Endotoxin is the commonest but not the only pyrogen, and a separate rabbit pyrogen test exists for the wider class.{{r|usp151}} This is why endotoxin and [[Sterility testing|sterility]] are separate determinations answering separate questions.{{r|usp85}} |
| 12 | 12 | ||
| + | 13 | Results are expressed in endotoxin units, normalised to mass for a drug substance or to volume for a solution. Compendial limits for parenteral products are calculated from the maximum dose, and a research-chemical certificate reporting an endotoxin figure without the basis of normalisation is difficult to interpret.{{r|usp1503}} | |
| + | 14 | ||
| 13 | == Methods == | 15 | == Methods == |
| 14 | Three variants are recognised. The gel-clot method observes whether a firm clot forms at a given dilution and gives a limit result rather than a number. The turbidimetric method follows the increase in turbidity as the cascade proceeds and is quantitative. The chromogenic method measures release of a coloured product from a synthetic substrate and is also quantitative.{{r|usp85}} | 16 | Three variants are recognised. The gel-clot method observes whether a firm clot forms at a given dilution and gives a limit result rather than a number. The turbidimetric method follows the increase in turbidity as the cascade proceeds and is quantitative. The chromogenic method measures release of a coloured product from a synthetic substrate and is also quantitative.{{r|usp85}} |
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| 21 | {{reflist}} | 23 | {{reflist}} |
| 22 | <ref name="usp85">United States Pharmacopeia, General Chapter <85>, ''Bacterial Endotoxins Test''.</ref> | 24 | <ref name="usp85">United States Pharmacopeia, General Chapter <85>, ''Bacterial Endotoxins Test''.</ref> |
| + | 25 | <ref name="usp1503">United States Pharmacopeia, General Chapter <1503>, ''Quality Attributes of Synthetic Peptide Drug Substances''.</ref> | |
| 23 | <ref name="usp151">United States Pharmacopeia, General Chapter <151>, ''Pyrogen Test''.</ref> | 26 | <ref name="usp151">United States Pharmacopeia, General Chapter <151>, ''Pyrogen Test''.</ref> |
| 24 | 27 | ||
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| 26 | [[Category:Compendial testing]] | 29 | [[Category:Compendial testing]] |
| 27 | [[Category:Analytical methods]] | 30 | [[Category:Analytical methods]] |
| + | 31 | [[Category:Quality and testing]] | |
| 28 | 32 |