The bacterial endotoxins test (BET) is unique because of its biases. Several biases in the BET are caused by the variability of standard endotoxin dilutions and the methodologies of the Limulus amebocyte lysate (LAL) test. The purpose of this study is to clarify those biases.   Bias from the Standard Endotoxin Dilutions   Operators for the BET often encounter variability of the potency in the standard endotoxin dilutions. To clarify the practical variability of the…

Figure 1: The bacterial endotoxins test (BET) is required for most parenteral drugs and medical devices that come into contact with the human bloodstream. Limulus amebocyte lysate (LAL) derived from horseshoe crabs is used for the BET, and several methodologies have been developed. Popular quantitative LAL techniques are the kinetic turbidimetric assay (KTA) and the kinetic chromogenic assay (KCA). It is, however, well known that the endotoxin standards used in both those assays are profoundly influenced by the techniques and…