Aminobenzoate Potassium Tablets
»Aminobenzoate Potassium Tablets contain not less than 90.0percent and not more than 110.0percent of the labeled amount of aminobenzoate potassium (C7H6KNO2).
Packaging and storage— Preserve in well-closed containers.
Identification— Proceed as directed for Aminobenzoate Potassium Capsules,using 1g of finely powdered Tablets.
Dissolution á711ñ—
Medium: water;900mL.
Apparatus 1: 100rpm.
Time: 45minutes.
Procedure— Determine the amount of C7H6KNO2dissolved by employing UVabsorption at the wavelength of maximum absorbance at about 270nm on filtered portions of the solution under test,suitably diluted with Medium,in comparison with a Standard solution having a known concentration of USP Aminobenzoate Potassium RSin the same Medium.
Tolerances— Not less than 75%(Q)of the labeled amount of C7H6KNO2is dissolved in 45minutes.
Uniformity of dosage units á905ñ: meet the requirements.
Assay—
Standard preparation— Prepare a solution of USP Aminobenzoate Potassium RShaving a known concentration of about 5µg per mL.
Assay preparation and Procedure—Weigh and finely powder not fewer than 20Tablets.Using a portion of the powdered Tablets,equivalent to about 100mg of aminobenzoate potassium,proceed as directed in the Assayunder Aminobenzoate Potassium Capsules.
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
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