Brompheniramine Maleate Tablets

This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition

Issued and maintained by the United States Pharmacopeial Convention (USP)

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Brompheniramine Maleate Tablets contain not less than 95.0 percent and not more than 105.0 percent of the labeled amount of C₁₆H₁₉BrN₂ · C₄H₄O₄

Packaging and storage-Preserve in tight containers.

USP REFERENCE STANDARDS (11)

USP Brompheniramine Maleate RS

1 Identification

Tablets meet the requirements under Identification-Organic Nitrogenous Bases (181).

DISSOLUTION (711)

Medium: water, 500 mL..

Apparatus 1: 100 rpm.

Time: 45 minutes.

Procedure-Determine the amount of C₁₆H₁₉BrN₂ · C₄H₄O₄, dissolved from UV absorbances at the wavelength of maximum absorbance at about 264 nm on filtered portions of the solution under test, suitably diluted with 3 N hydrochloric acid, using 5-cm cuvettes, in comparison with a Standard solution having a known concentration of USP Brompheniramine Maleate RS in the same Medium.

Tolerances-Not less than 75% (Q) of the labeled amount of C₁₆H₁₉BrN₂ · C₄H₄O₄, is dissolved in 45 minutes.

UNIFORMITY OF DOSAGE UNITS (905); meet the requirements.

2 Assay

Standard preparation-Dissolve an accurately weighed quantity of USP Brompheniramine Maleate RS in water, and dilute quantitatively with water to obtain a solution having a known concentration of about 160 µg per ml. Transfer 25.0 mL of this solution to a separator containing 25 mL of water, mix, and proceed as directed under Assay preparation, beginning with "adjust with sodium hydroxide solution (1 in 10) to a pH of 11." The concentration of USP Brompheniramine Maleate RS in the Standard preparation is about 20 µg per mL.

Assay preparation-Weigh and finely powder not fewer than 20 Tablets. Weigh accurately a portion of the powder, equivalent to about 4 mg of brompheniramine maleate, mix with 50 mL of water for 10 minutes, adjust with sodium hydroxide solution (1 in 10) to a pH of 11, and cool to room temperature. Extract the mixture with two 75-ml portions of solvent hexane, and combine the extracts in a second separator. Extract the solvent hexane solution with three 50-mL portions of dilute hydrochloric acid (1 in 120), combining the acid extracts in a 200-mL volumetric flask. Add dilute hydrochloric acid (1 in 120) to volume, and mix.

Procedure-Concomitantly determine the absorbances of the Assay preparation and the Standard preparation, in 1-cm cells at the wavelength of maximum absorbance at about 264 nm, with a suitable spectrophotometer, using dilute hydrochloric acid (1 in 120) as the blank. Calculate the quantity, in mg, of C₁₆H₁₉BrN₂ · C₄H₄O₄, in the portion of Tablets taken by the formula:

0.2C(A_u/A_s)

in which C is the concentration, in µg per mL, of USP Brompheniramine Maleate RS in the Standard preparation; and A_u and A_s are the absorbances of the Assay preparation and the Standard preparation, respectively.