USP-NF M98834_01_01

<88> Biological Reactivity Tests, In Vivo

Body

USP-NF

Number

USP-NF M98834_01_01

FDA recognition no.

2-294

Scope

Partial recognition. The following part(s) of the standard is (are) not recognized: Page 171, Sentences, "Remove particulate matter, such as lint and free particles, by treating each subdivided Sample or Negative Control as follows. Place the Sample into a clean, glass-stoppered, 100-mL graduated cylinder of Type I glass, and add about 70 mL of Water for Injection. Agitate for about 30 s, and drain off the water. Repeat this step." Pages 174-175, Section "Safety Tests - Biologicals."

Scope source: FDA 认可共识标准库

Laboratories covering this standard