USP-NF M98900_01_01

<151> Pyrogen Test (USP Rabbit Test)

Body

USP-NF

Number

USP-NF M98900_01_01

FDA recognition no.

2-295

Scope

Partial recognition. The following part(s) of the standard is (are) not recognized: Last sentence of first paragraph "A validated, equivalent in vitro pyrogen or bacterial endotoxin test may be used in place of the in vivo rabbit pyrogen test, where appropriate." Section "Radioactive Pharmaceuticals."

Scope source: FDA 认可共识标准库

Laboratories covering this standard