USP General Chapter 85: difference between revisions
Diff·revision 8 → 9·19:55, 25 Jan 2025
Difference between revision 8 and revision 9 of USP General Chapter 85. 11 lines changed; the page grew by 748 bytes.
| Revision 8 — 19:42, 8 Jan 2025 ChromCleanupCass (talk) correct the resolution formula — the denominator is the sum of the widths 2,668 bytes ±0 | Revision 9 — 19:55, 25 Jan 2025 DrTitration (talk) add the system-suitability criteria the method actually specifies 3,416 bytes +748 | ||
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| 5 | | Methods = Gel-clot, turbidimetric, chromogenic | 5 | | Methods = Gel-clot, turbidimetric, chromogenic |
| 6 | }} | 6 | }} |
| + | 7 | {{hatnote|For the test itself and how it is interpreted, see [[Bacterial endotoxin test]].}} | |
| 7 | 8 | ||
| 8 | '''USP General Chapter 85''', titled ''Bacterial Endotoxins Test'', is the chapter of the United States Pharmacopeia that prescribes how endotoxin is measured, how the limit for a product is calculated, and how method suitability is demonstrated.{{r|usp85}} | 9 | '''USP General Chapter 85''', titled ''Bacterial Endotoxins Test'', is the chapter of the United States Pharmacopeia that prescribes how endotoxin is measured, how the limit for a product is calculated, and how method suitability is demonstrated.{{r|usp85}} |
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| 19 | The maximum valid dilution follows from the limit and the lysate sensitivity, and constrains how far a sample may be diluted to overcome interference. Dilution is the usual remedy for interference, and the chapter bounds it so that dilution cannot be used to dilute the endotoxin below detection as well.{{r|usp85}} | 20 | The maximum valid dilution follows from the limit and the lysate sensitivity, and constrains how far a sample may be diluted to overcome interference. Dilution is the usual remedy for interference, and the chapter bounds it so that dilution cannot be used to dilute the endotoxin below detection as well.{{r|usp85}} |
| + | 21 | ||
| + | 22 | == Reading a citation on a certificate == | |
| + | 23 | A certificate stating "endotoxin: <0.5 EU/mg, USP <85>" is asserting that the determination followed the chapter. The fields that make that assertion checkable are the method variant used, the lysate sensitivity, and whether inhibition and enhancement testing was performed on this matrix.{{r|usp85}} | |
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| + | 25 | | Field | Why it matters | | |
| + | 26 | |---|---| | |
| + | 27 | | Method variant | Gel-clot gives a limit result, not a number | | |
| + | 28 | | Lysate sensitivity | Sets the achievable detection limit | | |
| + | 29 | | Interference testing | Without it, a low result may be inhibition | | |
| + | 30 | | Basis of normalisation | Per mg of what — substance, or vial contents? | | |
| 20 | 31 | ||
| 21 | == References == | 32 | == References == |