Establishment of Bacterial Endotoxin Test for ¹⁸F-16α-17β-Fluoroestradiol(18F-FES) Injection

OBJECTIVE To establish the method of bacterial endotoxin test for ¹⁸F-16α-17β-fluoroestradiol(¹⁸F-FES) injection. METHODS The test procedure was carried out according to the bacterial endotoxin test in China Pharmacopoeia (2010) VolumeⅡ. RESULTS Ten-fold dilution of ¹⁸F-FES injection had no interferential effect on the bacterial endotoxin test. The limit value of the bacterial endotoxin was 5 EU·mL^-1. The results of bacterial endotoxin test were conformed to the required stipulation in 10 batches of samples. CONCLUSION The method of bacterial endotoxin test can be used to control the quality of 18F-FES injection.