Sodium Nitrite Injection
» Sodium Nitrite Injection is a sterile solution of Sodium Nitrite in Water for Injection. It contains not less than 95.0 percent and not more than 105.0 percent of the labeled amount of NaNO2.
Packaging and storage Preserve in single-dose containers, of Type I glass.
Bacterial endotoxins 85 It contains not more than 0.33 USP Endotoxin Unit per mg of sodium nitrite.
pH 791: between 7.0 and 9.0.
Other requirements It meets the requirements under Injections 1.
Assay Pipet an accurately measured volume of Injection, containing about 150 mg of sodium nitrite into a mixture of 50.0 mL of 0.1 N potassium permanganate VS, 100 mL of water, and 5 mL of sulfuric acid, immersing the tip of the pipet beneath the surface of the mixture during the addition. Warm the liquid to 40, allow it to stand for 5 minutes, and add 25.0 mL of 0.1 N oxalic acid VS. Heat the mixture to about 80, and titrate with 0.1 N potassium permanganate VS. Each mL of 0.1 N potassium permanganate is equivalent to 3.450 mg of NaNO2.
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USP32NF27 Page 3579