Preparation and quality control of sulphur colloid kit

This study shows the preparation method of sulphur colloid kit according to the radiopharmaceuticals requirements , to be used for retricloendothelial system imaging of liver and spleen after labeling with technetium 99 m. Sulphur colloid kit consists of three vials : the first contains 1.5 ml of 0.148 N hydrochloric acid , the second contains lyophilized sodium thiosulphate 3.14 mg , gelatin 18.1 mg ,EDTA-2Na-2H2O 2.5 mg , the third vial contains phosphate buffer ph=7.5, NaOH 11.8 mg , NaH2PO4.2H2O 48 mg. The prepared kit showed high quality satisfying the requirement of USP from the point of physical, radiochemical and biological purities and its validity for human injection. The labelled kit exceeded 98%, The biodistribution study in rats showed that about 90% of the injected dose is localized in liver and spleen after 20 minutes, while less than 2%,1% of it are localized in lungs and kidneys respectively. The stability studies shows that the labelled formulation is stable for 8 hours at room temperature, the cold kit is stable for more than 6 months. (Authors)