Hope Medical Enterprise; Inc. d.b.a. Hope Pharmaceuticals
发明人:
SHERMAN, Craig,SMITH, Catherine Marie,WIRTZ, Kevin Robert,SCHULZE, Erich
申请号：
ES10797770
公开号：
ES2655883T3
申请日:
2010.07.07
申请国别(地区):
ES
年份:
2018
代理人:
摘要：
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.Tiosulfato de sodio pentahidratado que contiene no más de 10 ppm de carbono orgánic
