Brompheniramine Maleate Tablets

» 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.

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USP Brompheniramine Maleate RS

Identification— Tablets meet the requirements under Identification—Organic Nitrogenous Bases

181

Dissolution

711

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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.

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 C16H19Br N2·C4H4O4 in the portion of Tablets taken by the formula:

0.2C(AU / AS)

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

Auxiliary Information— Please check for your question in the FAQs before contacting USP.

Topic/Question	Contact	Expert Committee
Monograph	Domenick Vicchio, Ph.D. Senior Scientific Liaison 1-301-998-6828	(SM42010) Monographs - Small Molecules 4
Reference Standards	RS Technical Services 1-301-816-8129 rstech@usp.org
711	Margareth R.C. Marques, Ph.D. Senior Scientific Liaison 1-301-816-8106	(GCDF2010) General Chapters - Dosage Forms

USP35–NF30 Page 2393

Pharmacopeial Forum: Volume No. 30(6) Page 1978