Details for Patent: 9,687,505

Title:	Sodium nitrite-containing pharmaceutical compositions
Abstract:	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.
Inventor(s):	Sherman; Craig (Scottsdale, AZ), Lepine; Anthony James (Greendale, WI), Smith; Catherine Marie (Grafton, WI), Wirtz; Kevin Robert (Belgium, WI), Schulze; Erich (Mission Viejo, CA)
Assignee:	Hope Medical Enterprises, Inc. (Scottsdale, AZ)
Filing Date:	Aug 29, 2016
Application Number:	15/249,746
Claims:	1. A kit comprising a pressurized container, a pump, an atomizer or a nebulizer and sodium nitrite, 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 non-volatile organic carbon content is no greater than 10 ppm, and contains no greater than 0.25 EU/mg of bacterial endotoxins; wherein the sodium nitrite contains no less than 98% by weight of sodium nitrite; wherein the sodium nitrite contains no less than 99.8% by weight of sodium nitrite as measured by Ion Chromatography analysis; wherein a 10% aqueous solution of the sodium nitrite at 25.degree. C. has a pH value between 8 and 9; and 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. 2. The kit of claim 1, comprising a pressurized container. 3. The kit of claim 1, comprising a pump. 4. The kit of claim 1, comprising an atomizer. 5. The kit of claim 1, comprising a nebulizer.