Gram negative bacterial contamination. Low endotoxin concentration indicates care in collection and processing of bovine blood, serum, and manufacturing. Endotoxin is not removed by filtration and can affect cell growth characteristics.
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USP <85> | Bacterial Endotoxins Test | Portions have been harmonized with EP and/or JP. Test to detect or quantify endotoxins from Gram-negative bacteria using amoebocyte lysate from the horseshoe crab. Three techniques: gel-clot- based on gel formation; turbidimetric-based on development of rabidity after cleavage of an endogenous substrate; and chromogenic technique-based on the development of color after cleavage of a synthetic peptide-chromogen complex. | |||||||||||||||||
EP 2.6.14 | Bacterial Endotoxins | Test to detect or quantify endotoxins from Gram-negative bacteria using amoebocyte lysate from the horseshoe crab. Three techniques: gel-clot- based on gel formation; turbidimetric-based on development of rabidity after cleavage of an endogenous substrate; and chromogenic technique-based on the development of color after cleavage of a synthetic peptide-chromogen complex. 6 Methods:
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EP 5.1.10 | Guidelines for using the test for bacterial endotoxins | Method A is no longer declares as the reference method, and all methods A to F can be used. Where the method is stated in the monograph, the use of another method must be validated. Reference is made to the use of alternative reagent to the LAL such as recombinant factor C. | |||||||||||||||||
JP 4.01 | Bacterial Endotoxin Test | Test to detect or quantify bacterial endotoxin of gram-negative bacterial origin using an amoebocyte lysate prepared from blood corpuscle extracts of horseshoe crab (Limulus Polyphemus or Tachypleus tridentatus). Two types: Gel-clot, based on gel formation by the reaction of the lysate TS with endotoxins; and photometric, based on endotoxin-induced optical changes of the lysate TS including the turbidimetric technique. |