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SODIUM NITRITE-CONTAINING PHARMACEUTICAL COMPOSITIONS
专利权人:
Hope Medical Enterprise; Inc. d.b.a. Hope Pharmaceuticals
发明人:
Sherman, Craig,Lepine, Anthony James,Smith, Catherine Marie,Wirtz, Kevin Robert,Schulze, Erich
申请号:
AU2020201059
公开号:
AU2020201059A1
申请日:
2020.02.14
申请国别(地区):
AU
年份:
2020
代理人:
摘要:
#$%^&*AU2020201059A120200305.pdf#####ABSTRACT A pharmaceutical composition comprising sodium nitrite and ethylenediaminetetraacetic acid (EDTA), wherein the sodium nitrite contains no greater than 0.02% by weight of sodium carbonate, contains no greater than 10 ppm of an anti-caking agent, has a loss on drying of no greater than 0.25% by weight, wherein the water content is no greater than 0.5% by weight, wherein the heavy metal content is no greater than 10 ppm, contains no greater than 0.4% by weight of sodium nitrate, contains no greater than 0.005% by weight of insoluble matter, contains no greater than 0.005% by weight of chloride, contains no greater than 0.01% by weight of sulfate, contains no greater than 0.001% by weight of iron, contains no greater than 0.01% by weight of calcium, contains no greater than 0.005% by weight of potassium, contains no greater than 0.05 ppm of mercury, contains no greater than 2 ppm of aluminum, contains no greater than 3 ppm of arsenic, contains no greater than 0.003% by weight of selenium, contains no greater than 5000 ppm of ethanol, contains no greater than 3000 ppm methanol, wherein the total nonvolatile organic carbon content is no greater than 10 ppm, and contains no greater than 0.25 EU/mg of bacterial endotoxins.
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