SODIUM THIOSULFATE-CONTAINING PHARMACEUTICAL COMPOSITION

摘要

PROBLEM TO BE SOLVED: To provide a pharmaceutically acceptable sodium thiosulfate, and to provide its pharmaceutical composition.SOLUTION: Pharmaceutical grade sodium thiosulfate pentahydrate contains: 10 ppm or lower of non-purgeable organic carbon; 0.05 ppm or lower of mercury; 2 ppm or lower of aluminum; 0.003% by weight of selenium; 98% to 102% by weight of sodium thiosulfate on an anhydrous basis, measured by ion chromatography; and a water content of 32% to 37% by weight, wherein it has total aerobic count of microbial load of 100 CFU/g or lower, has total yeast and mold count of 20 CFU/g or lower, contains 0.02 EU/mg or lower of bacterial endotoxins. A 10% aqueous solution of the solid sodium thiosulfate pentahydrate at 25°C is colorless and has a pH of 6.0 to 8.0.SELECTED DRAWING: None