Quinidine Sulfate Tablets
»Quinidine Sulfate Tablets contain amounts of quinidine sulfate and dihydroquinidine sulfate totaling not less than 90.0percent and not more than 110.0percent of the labeled amount of quinidine sulfate,calculated as (C20H24N2O2)2·H2SO4·2H2O.
Packaging and storage— Preserve in well-closed,light-resistant containers.
Identification— The Tablets meet the requirements of the tests for Identificationunder Quinidine Sulfate Capsules,powdered Tablets being used in place of the contents of capsules.
Dissolution á711ñ—
Medium: 0.01Nhydrochloric acid;900mL.
Apparatus 1: 100rpm.
Time: 30minutes.
Procedure— Determine the amount of (C20H24N2O2)2·H2SO4·2H2Odissolved by employing UVabsorption at the wavelength of maximumm absorbance at about 248nm on filtered portions of the solution under test,suitably diluted with Dissolution Medium,in comparison with a Standard solution having a known concentration of USP Quinidine Sulfate RSin the same Medium.
Tolerances— Not less than 85%(Q)of the labeled amount of (C20H24N2O2)2·H2SO4·2H2Ois dissolved in 30minutes.
Uniformity of dosage units á905ñ: meet the requirements.
Procedure for content uniformity— Proceed as directed for Procedure for content uniformityin the test for Uniformity of dosage unitsunder Quinidine Sulfate Capsules,using 1powdered Tablet instead of the contents of 1Capsule.
Chromatographic purity— Shake a quantity of powdered Tablets,equivalent to about 150mg of quinidine sulfate,with 25mLof diluted alcohol for 10minutes,and filter.Using the filtrate as the test solution,proceed as directed in the test for Chromatographic purityunder Quinidine Sulfate.
Assay— Proceed as directed in the Assayunder Quinidine Sulfate Capsules,using powdered Tablets.
Auxiliary Information— Staff Liaison:Andrzej Wilk,Ph.D.,Senior Scientific Associate
Expert Committee:(PA5)Pharmaceutical Analysis 5
USP28–NF23Page 1696
Phone Number:1-301-816-8305