Bacterial endotoxin is a kind of pyrogen, injecting overweight bacterial endotoxin of cefotaxime sodium can cause a series of adverse reaction, so bacterial endotoxin should be controlled in cefotaxime sodium sterile bulk. The harm of bacterial endotoxin was introduced, and the no interferencerange detection concentration was validated ,which was 1.25~5.0 mg/mL, when using 0.06 EU/mL TAL to test the bacterial endotoxin residue by gel method.The routine test concentration of cefotaxime sodium was established ,which was 1.5 mg/mL.According to the feature of bacterial endotoxin and production, bacterial endotoxin should be control in the process water, raw materials, containers and tools cleaning and aseptic process design.