<85> BACTERIAL ENDOTOXINS TEST
Second Supplement to USP 35 NF 30Biological tests / 85 BACTERIAL ENDOTOXINS Test5625General ChaptersGeneral tests and AssaysREAGENTS AND TEST SOLUTIONSBiological tests andAmoebocyte Lysate A lyophilized product obtainedAssaysfrom the lysate of amoebocytes (white blood cells) from thehorseshoe crab (Limulus polyphemus or Tachypleustridentatus). This reagent refers only to a product manufac-tured in accordance with the regulations of the competentauthority. [NOTE Amoebocyte Lysate reacts to some b-glu-cans in addition to ENDOTOXINS . Amoebocyte Lysate prepara- 85 BACTERIAL ENDOTOXINStions that do not react to glucans are available: they areprepared by removing the G factor reacting to glucans fromTESTAmoebocyte Lysate or by inhibiting the G factor reacting sys-tem of Amoebocyte Lysate and may be used f]
Second Supplement to USP 35–NF 30 Biological Tests / 〈85〉 Bacterial Endotoxins Test 5627 Table 1. Preparation of Solutions for the Inhibition/Enhancement Test for Gel-Clot Techniques (Continued) Endotoxin Concentration/ Solution to Which Endotoxin Dilution Endotoxin Number of Solution Is Added Diluent Factor Concentration Replicates 8 0 ...
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