Packaging and storage— Preserve in single-dose or in multiple-dose containers,preferably of Type Iglass,protected from light.

USP Reference standards á11ñ— USP Brompheniramine Maleate RS.USP Endotoxin RS.

Identification— Dilute a volume of Injection,equivalent to about 50mg of brompheniramine maleate,with dilute hydrochloric acid (1in 1200)to 25mL,and proceed as directed under Identification—Organic Nitrogenous Bases á181ñ,beginning with “Transfer the liquid to a separator:”the Injection meets the requirements of the test.

Bacterial endotoxins á85ñ— It contains not more than 35.7USP Endotoxin Units per mg of brompheniramine maleate.

pHá791ñ: between 6.3and 7.3.

Other requirements— It meets the requirements under Injections á1ñ.

Assay— Proceed with Injection as directed under Salts of Organic Nitrogenous Bases á501ñ,to prepare the solution employed for the determination of the absorbance,AU,at 262nm.For the determination of AS,dissolve about 25mg of USP Brompheniramine Maleate RS,accurately weighed,in 20mLof dilute sulfuric acid (1in 350),and treat this solution the same as the portion of Injection being assayed.Calculate the quantity,in mg,of C16H19BrN2·C4H4O4in each mLof the Injection taken by the formula: in which Wis the weight,in mg,of USP Brompheniramine Maleate RSin the Standard Preparation,and Vis the volume,in mL,of Injection taken.

Expert Committee:(PA1)Pharmaceutical Analysis 1

USP28–NF23Page 288

Phone Number:1-301-816-8379