| abstract |
Sodium thiosulfate pentahydrate containing no more than 10 ppm of non-purgeable organic carbon, contains no more than 0.01% by weight of carbonate, contains no more than 0.05 ppm of mercury, no more than 2 ppm of aluminum; Contains no more than 0.003% by weight of selenium, contains no less than 99% by weight and no more than 100.5% by weight of sodium thiosulfate on an anhydrous basis measured by colorimetric analysis or not less than 98% by weight and no more than 102% by weight of sodium thiosulfate on an anhydrous basis measured by ion chromatography, it has a water content between 32% and 37% by weight, it has a heavy metal content of no more than 10 ppm, it contains no more of 200 ppm of chloride, contains no more than 0.001% by weight of sulfide, contains no more than 0.002% by weight of iron, contains no more than 0.01% by weight of calcium, contains no more than 0.005% by weight of potassium, contains no more than 0.1% sulphite, contains no more than 0.5% sulfate, contains no more than 3 ppm of arsenic, contains no more than 0.001% by weight of lead, has a total aerobic count of Microbial load of no more than 100 CFU / g, has a total yeast and mold count of no more than 20 CFU / g, contains no more than 0.0 2 EU / mg of bacterial endotoxins, contains no more than 0.002% by weight of nitrogen compounds, contains no more than 0.005% by weight of insoluble matter, has a positive identification test for sodium, has a positive identification test for thiosulfate, It does not cause turbidity when exposed to ammonium oxalate, contains no more than 0.01% by weight of residual anti-binder agent, and contains no more than ICH Q3C limits of volatile organic impurities, where a 10% solution of thiosulfate Sodium pentahydrate at 25 ° C is colorless and has a pH between 6.0 and 8.0, and where sodium pentahydrate thiosulfate are odorless crystals or has the appearance of colorless crystals. |