Sodium Nitrite Injection
»Sodium Nitrite Injection is a sterile solution of Sodium Nitrite in Water for Injection.It contains not less than 95.0percent and not more than 105.0percent of the labeled amount of NaNO2.
Packaging and storage— Preserve in single-dose containers,of Type Iglass.
Identification— It responds to the Identificationtests under Sodium Nitrite.
Bacterial endotoxins á85ñ— It contains not more than 0.33USP Endotoxin Unit per mg of sodium nitrite.
pHá791ñ: between 7.0and 9.0.
Other requirements— It meets the requirements under Injections á1ñ.
Assay— Pipet an accurately measured volume of Injection,containing about 150mg of sodium nitrite into a mixture of 50.0mLof 0.1Npotassium permanganate VS,100mLof water,and 5mLof 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 5minutes,and add 25.0mLof 0.1Noxalic acid VS.Heat the mixture to about 80,and titrate with 0.1Npotassium permanganate VS.Each mLof 0.1Npotassium permanganate is equivalent to 3.450mg of NaNO2.
Auxiliary Information— Staff Liaison:Andrzej Wilk,Ph.D.,Senior Scientific Associate
Expert Committee:(PA5)Pharmaceutical Analysis 5
USP28–NF23Page 1789
Phone Number:1-301-816-8305