Abstract:

In the present study, we aimed to establish the 8^th National Standard of Endotoxin using three batches of proposedNational Standard of Endotoxin. We co-calibrated the potency of the proposed preparations against the 3^rd International Standard (10/178) using the gel-clot method, kinetic-turbidimetric test and kinetic-chromogenic test. A total of 14 laboratories participated in this collaborative study. By comparing precision of three approved candidates’ calibrationresults and analyzing the differences among the three results from different methods, we ultimately selected one of candidates as 8^th National Standard of Endotoxin, and its potency is 9000 EU/ampoule and lot is 150801-201601.

Key words: Endotoxin, National standard, Preparation, Collaborative study