USP General Chapter 85: difference between revisions
Diff·revision 1 → 2·04:11, 19 Oct 2024
Difference between revision 1 and revision 2 of USP General Chapter 85. 5 lines changed; the page grew by 810 bytes.
| Revision 1 — 05:56, 15 Oct 2024 SigFigSindri (talk) create article — method stub 1,276 bytes +1,276 | Revision 2 — 04:11, 19 Oct 2024 IsocraticIla (talk) rm the assertion that two laboratories must agree; they need not 2,086 bytes +810 | ||
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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 | == 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}} | |
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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. | |
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| 12 | == References == | 17 | == References == |
| 13 | {{reflist}} | 18 | {{reflist}} |