Packaging and storage— Preserve in single-dose containers, of Type I glass.

USP Reference standards 11— USP Endotoxin RS.

Identification— It responds to the Identification tests under Sodium Nitrite.

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.

Residual solvents 467: meets the requirements.

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.

Expert Committee : (MDCV05) Monograph Development-Cardiovascular

USP29–NF24 Page 1986

Phone Number : 1-301-816-8305