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

USP Reference standards 11— USP Brompheniramine Maleate RS. USP Endotoxin RS.

Identification— Dilute a volume of Injection, equivalent to about 50 mg of brompheniramine maleate, with dilute hydrochloric acid (1 in 1200) to 25 mL, and proceed as directed under Identification—Organic Nitrogenous Bases 181, beginning with “Transfer the liquid to a separator:” the Injection meets the requirements of the test.

Bacterial endotoxins 85— It contains not more than 35.7 USP Endotoxin Units per mg of brompheniramine maleate.

pH 791: between 6.3 and 7.3.

Residual solvents 467: meets the requirements.

Other requirements— It meets the requirements under Injections 1.

Assay— Proceed with Injection as directed under Salts of Organic Nitrogenous Bases 501, to prepare the solution employed for the determination of the absorbance, AU, at 262 nm. For the determination of AS, dissolve about 25 mg of USP Brompheniramine Maleate RS, accurately weighed, in 20 mL of dilute sulfuric acid (1 in 350), and treat this solution the same as the portion of Injection being assayed. Calculate the quantity, in mg, of C16H19BrN2·C4H4O4 in each mL of the Injection taken by the formula: in which W is the weight, in mg, of USP Brompheniramine Maleate RS in the Standard Preparation, and V is the volume, in mL, of Injection taken.

Expert Committee : (MDPS05) Monograph Development-Pulmonary and Steroids

USP29–NF24 Page 312

Phone Number : 1-301-816-8143