USP General Chapter 85 (revision 2)
Old revision·04:11, 19 Oct 2024·IsocraticIla
| USP General Chapter 85 | |
|---|---|
| Title | Bacterial Endotoxins Test |
| Status | General chapter below 1000, and therefore mandatory where referenced |
| Methods | Gel-clot, turbidimetric, chromogenic |
| Topic infobox · conventions | |
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.[1]
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.[2]
What the chapter specifies
[edit]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.[1]
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.