Sodium nitrite-containing pharmaceutical compositions
Provided herein are pharmaceutically acceptable sodium nitrite and pharmaceutical compositions thereof. Also provided herein are methods for determining the total non-volatile organic carbon in a sodium nitrite-containing sample. Further provided herein are methods for producing pharmaceutically acceptable sodium nitrite. Still further provided herein are methods of treatment comprising the administration of pharmaceutically acceptable sodium nitrite.
1. A method for treating, preventing, or reducing the risk of a hospital-acquired infection comprising administering to a subject having or at risk for having a hospital-acquired infection a therapeutically effective amount of sodium nitrite which 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 non-volatile organic carbon content is no greater than 10 ppm, and contains no greater than 0.25 EU/mg of bacterial endotoxins.
2. The method of claim 1 , wherein the sodium nitrite contains no less than 97% by weight of sodium nitrite.
3. The method of claim 1 , wherein the sodium nitrite contains no less than 98% by weight of sodium nitrite.
4. The method of claim 1 , wherein the sodium nitrite contains no less than 99.8% by weight of sodium nitrite as measured by Ion Chromatography analysis.
5. The method of claim 1 , wherein the sodium nitrite is a white solid.
6. The method of claim 1 , wherein a 10% aqueous solution of the sodium nitrite at 25 has a pH value between 8 and 9.
7. method of claim 1 , wherein the sodium nitrite has total aerobic count of microbial load of no greater than 100 CFU/g and has total yeast and mold count of no greater than 20 CFU/g.