USP General Chapter 85: difference between revisions
Diff·revision 4 → 5·04:14, 19 Nov 2024
Difference between revision 4 and revision 5 of USP General Chapter 85. 5 lines changed; the page grew by 582 bytes.
| Revision 4 — 02:45, 7 Nov 2024 UnitsUrsula (talk) state the column chemistry and the gradient the figure was obtained on 2,086 bytes ±0 | Revision 5 — 04:14, 19 Nov 2024 OffLabelOdile (talk) British spelling per PP:MOS 2,668 bytes +582 | ||
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| 10 | Chapters numbered below 1000 are mandatory where a monograph or another applicable requirement references them; chapters numbered 1000 and above are informational. This distinction matters when reading a certificate that cites a chapter, because citing an informational chapter is a different kind of claim from citing a mandatory one.{{r|usp_general}} | 10 | Chapters numbered below 1000 are mandatory where a monograph or another applicable requirement references them; chapters numbered 1000 and above are informational. This distinction matters when reading a certificate that cites a chapter, because citing an informational chapter is a different kind of claim from citing a mandatory one.{{r|usp_general}} |
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| + | 12 | The chapter is harmonised in substance with the corresponding chapters of the European and Japanese pharmacopoeias, so a determination described as conforming to one is broadly comparable with one conforming to another.{{r|usp85}} | |
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| 12 | == What the chapter specifies == | 14 | == What the chapter specifies == |
| 13 | The chapter defines the three permitted techniques — gel-clot, turbidimetric and chromogenic — and treats the gel-clot method as the referee method where results conflict. It specifies preparation of the standard endotoxin, the confirmation of lysate sensitivity, and the inhibition and enhancement testing that establishes whether a particular sample matrix interferes with the reaction.{{r|usp85}} | 15 | The chapter defines the three permitted techniques — gel-clot, turbidimetric and chromogenic — and treats the gel-clot method as the referee method where results conflict. It specifies preparation of the standard endotoxin, the confirmation of lysate sensitivity, and the inhibition and enhancement testing that establishes whether a particular sample matrix interferes with the reaction.{{r|usp85}} |
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| 15 | It also specifies how the endotoxin limit for a product is calculated. The limit derives from the threshold pyrogenic dose and the maximum human dose per kilogram per hour, so a limit expressed per milligram of substance depends on the dose that substance is given at. Two products with the same per-milligram figure may sit on opposite sides of their respective limits. | 17 | It also specifies how the endotoxin limit for a product is calculated. The limit derives from the threshold pyrogenic dose and the maximum human dose per kilogram per hour, so a limit expressed per milligram of substance depends on the dose that substance is given at. Two products with the same per-milligram figure may sit on opposite sides of their respective limits. |
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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}} | |
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| 17 | == References == | 21 | == References == |
| 18 | {{reflist}} | 22 | {{reflist}} |
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| 23 | [[Category:Compendial testing]] | 27 | [[Category:Compendial testing]] |
| 24 | [[Category:Analytical science]] | 28 | [[Category:Analytical science]] |
| + | 29 | [[Category:Quality and testing]] | |
| 25 | 30 |