USP Monographs: Aminobenzoate Potassium for Oral Solution

Aminobenzoate Potassium for Oral Solution

» Aminobenzoate Potassium for Oral Solution contains not less than 90.0 percent and not more than 110.0 percent of the labeled amount of aminobenzoate potassium (C7H6KNO2).

Packaging and storage— Preserve in tight containers.

USP Reference standards

— USP Aminobenzoate Potassium RS.

Identification—

A: Ultraviolet Absorption

197U

—

Solution: 50 µg per mL.

Medium: water.

B: Dissolve about 400 mg in 10 mL of water, add 1 mL of 3 N hydrochloric acid, filter, and wash the precipitate with two 5-mL portions of cold water. Recrystallize from alcohol the precipitate so obtained, and dry at 110

for 1 hour: the p-aminobenzoic acid so obtained melts between 186

and 189

Minimum fill

755

—

FOR SOLID PACKAGED IN MULTIPLE-UNIT CONTAINERS: meets the requirements.

Uniformity of dosage units

905

—

FOR SOLID PACKAGED IN SINGLE-UNIT CONTAINERS: meets the requirements.

791

: between 7.0 and 9.0, in a solution (1 in 10).

Residual solvents

467

: meets the requirements.

(Official January 1, 2007)

Assay— Transfer about 100 mg of Aminobenzoate Potassium for Oral Solution, accurately weighed, to a suitable vessel, add 5 mL of hydrochloric acid and 50 mL of water, mix, cool to 15

, and add 25 g of crushed ice. Titrate with 0.1 M sodium nitrite VS, determining the endpoint potentiometrically, using a calomel-platinum electrode system. Each mL of 0.1 M sodium nitrite is equivalent to 17.52 mg of aminobenzoate potassium (C7H6KNO2).

Auxiliary Information— Staff Liaison : Clydewyn M. Anthony, Ph.D., Scientist

Expert Committee : (MDCCA05) Monograph Development-Cough Cold and Analgesics

USP29–NF24 Page 132

Phone Number : 1-301-816-8139


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