Aminobenzoate Potassium for Oral Solution, chemical structure, molecular formula, Reference Standards

Aminobenzoate Potassium for Oral Solution

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

Packaging and storage— Preserve in tight containers.

USP Reference standards á11ñ— USP Aminobenzoate Potassium RS.

Identification—

A: Ultraviolet Absorption á197Uñ—

Solution: 50µg per mL.

Medium: water.

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

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

and 189

Minimum fill á755ñ—

FORSOLID PACKAGED IN MULTIPLE-UNIT CONTAINERS: meets the requirements.

Uniformity of dosage units á905ñ—

FORSOLID PACKAGED IN SINGLE-UNIT CONTAINERS: meets the requirements.

pHá791ñ: between 7.0and 9.0,in a solution (1in 10).

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

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

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

Expert Committee:(PA2)Pharmaceutical Analysis 2

USP28–NF23Page 121

Phone Number:1-301-816-8139