Establishment of Bacterial Endotoxin Test and Sterility Test of Sodium Fluoride¹⁸F Injection

To establish the methods for the bacterial endotoxin test and the sterility test of Sodium Fluoride¹⁸F Injection. The Gel-clot method and the direct inoculation method was carried out according to the 2015 version of Chinese Pharmacopoeia (Vol.Ⅳ). The interferencing factors of bacterial endotoxin test were determined with two lachypleus amebocyte lysate from different producers. The interference can be eliminated after the sample was diluted to 10 times. The suitability test of sterility test indicated that the direct inoculation method can be used with 0.2 mL samples inoculated into 7.5 mL medium to conduct the sterility analysis. The results indicate that the Gel-clot method and the direct inoculation method could be used for the quality contral of Sodium Fluoride¹⁸F Injection. The methods are applicable, accurate, easy operated, rapid, economical and less-productive of radioactive waste.