USP <85> Bacterial Endotoxins Test
GPTKB entity
Statements (22)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
pharmacopoeial standard
|
| gptkbp:alternativeTo |
rabbit pyrogen test
|
| gptkbp:appliesTo |
medical devices
pharmaceutical products |
| https://www.w3.org/2000/01/rdf-schema#label |
USP <85> Bacterial Endotoxins Test
|
| gptkbp:method |
Limulus Amebocyte Lysate (LAL) test
chromogenic method gel-clot method turbidimetric method |
| gptkbp:publishedBy |
gptkb:United_States_Pharmacopeia_(USP)
|
| gptkbp:purpose |
detect bacterial endotoxins
|
| gptkbp:regulates |
endotoxin limits in medical devices
endotoxin limits in parenteral drugs |
| gptkbp:requires |
gptkb:FDA
|
| gptkbp:section |
United States Pharmacopeia (USP) compendium
|
| gptkbp:standardizedBy |
Control Standard Endotoxin (CSE)
Reference Standard Endotoxin (RSE) |
| gptkbp:usedFor |
quality control
sterility assurance batch release testing |
| gptkbp:bfsParent |
gptkb:USP_Microbiology_Standards
|
| gptkbp:bfsLayer |
7
|