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Quinidine Sulfate Tablets
» Quinidine Sulfate Tablets contain amounts of quinidine sulfate and dihydroquinidine sulfate totaling not less than 90.0 percent and not more than 110.0 percent 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 Identification under Quinidine Sulfate Capsules, powdered Tablets being used in place of the contents of capsules.
Dissolution 711—
Medium: 0.01 N hydrochloric acid; 900 mL.
Apparatus 1: 100 rpm.
Time: 30 minutes.
Procedure— Determine the amount of (C20H24N2O2)2·H2SO4·2H2O dissolved by employing UV absorption at the wavelength of maximumm absorbance at about 248 nm 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 RS in the same Medium.
Tolerances— Not less than 85% (Q) of the labeled amount of (C20H24N2O2)2·H2SO4·2H2O is dissolved in 30 minutes.
Uniformity of dosage units 905: meet the requirements.
Procedure for content uniformity— Proceed as directed for Procedure for content uniformity in the test for Uniformity of dosage units under Quinidine Sulfate Capsules, using 1 powdered Tablet instead of the contents of 1 Capsule.
Chromatographic purity— Shake a quantity of powdered Tablets, equivalent to about 150 mg of quinidine sulfate, with 25 mL of diluted alcohol for 10 minutes, and filter. Using the filtrate as the test solution, proceed as directed in the test for Chromatographic purity under Quinidine Sulfate.
Residual solvents 467: meet the requirements.
(Official January 1, 2007)
Assay— Proceed as directed in the Assay under Quinidine Sulfate Capsules, using powdered Tablets.
Auxiliary Information— Staff Liaison : Andrzej Wilk, Ph.D., Senior Scientific Associate
Expert Committee : (MDCV05) Monograph Development-Cardiovascular
USP29–NF24 Page 1884
Phone Number : 1-301-816-8305