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 11
Solution: 50 µg per mL.
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.
pH 791: between 7.0 and 9.0, in a solution (1 in 10).
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).
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USP35NF30 Page 2165