Abstract: Objective To establish a quality standard for the bacterial endotoxin test method of adenosine cobalt amine for injection, so as to provide reference for the formulation and revision of the national standard for this drug. Methods According to the 1143 bacterial endotoxin test method in the 2020 edition (Part 4) of the Chinese Pharmacopoeia, bacterial endotoxin test methodology was studied on 24 batches of adenosine cobalt amine injection from 8 production enterprises using different manufacturers of horseshoe crab reagents. Results A bacterial endotoxin limit of 40 EU·mg^-1 for adenosine cobalt amine injection was established, which was suitable for the examination of 1143 bacterial endotoxin detection methods in the four general principles of the Chinese Pharmacopoeia in 2020. Conclusion Adenosylcobalamin for injection can be controlled by bacterial endotoxin examination, and the limit of bacterial endotoxin can be set as follows, the content of endotoxin per mg of adenosylcobalamin shall not exceed 40 EU.

Key words: adenosylcobalamin for injection, bacterial endotoxin, methodological research, limits, interference test, quality control