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USP General Chapter 85 (revision 1)

Old revision·05:56, 15 Oct 2024·SigFigSindri

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USP General Chapter 85
TitleBacterial Endotoxins Test
StatusGeneral chapter below 1000, and therefore mandatory where referenced
MethodsGel-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]

References

  1. ^ United States Pharmacopeia, General Chapter <85>, Bacterial Endotoxins Test.
  2. ^ United States Pharmacopeia, General Notices and Requirements, section 3 (conformance to standards) and the numbering convention for general chapters.
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