Application of Micro-kinetic Chromogenic Method in Endotoxin Quantitative Detection of Hydroxypropyl-β-cyclodextrin

Abstract

The kinetic chromogenic assay with Limulus amoebocyte lysate to detect the bacterial endotoxin in Hydroxypropyl-β-cyclodextrin for injection is investigated in this paper. The test for interfering factors is performed to study the applicability of the kinetic chromogenic assay for detection of bacterial endotoxin in Hydroxypropyl-β-cyclodextrin for injection. The results suggest that r>0.980 while the range is between 50-0.005EU/ml. Besides, when concentration of test solution is 1mg/ml for Hydroxypropyl-β-cyclodextrin, there is no interference between Limulus amebocyte lysate and bacterial endotoxin. The kinetic chromogenic assay can be used to detect the bacterial endotoxin in Hydroxypropyl- -β-cyclodextrin.