12 December 1985
COMMERCIAL ITEM DESCRIPTION
QUINIDINE POLYGALACTURONATE TABLETS
The General Services Administration has authorized the use of this commercial item description in preference to MIL-Q-37779A.
The Commercial Item Description covers Quinidine Polygalacturonate Tablets for use as a cardiac drug.
Shall be Quinidine Polygalacturonate Tablets.
Shall contain 275 mg of Quinidine Polygalacturonate per tablet (equivalent to 166.25 mg of Quinidine Base) within the applicable assay limits for the tablets when assayed using a suitable, accurate and reproducible method.
Each tablet shall contain the equivalent of not less than 156.3 mg and not more than 176.2 mg of Quinidine Base when assayed using a suitable, accurate and reproducible method.
Shall contain not more than 6 mg of Free Quinidine per tablet when tested using the following procedure or by an equivalent accurate and reproducible method:
Transfer a sample of powdered tablet material (sugar coating, if present shall be removed by carefully washing with water and drying) to a small beaker. Add 100 ml of ether, mix and filter into a tared beaker. Wash the residue with two 5 ml portions of ether and filter into the beaker. Evaporate on a steam bath to dryness and dry at 105oC for four hours and weigh.
Wt. of Residue (mg) x Avg. Wt. of Tablets =
Wt. of Sample (mg)
Wt. (mg) of Free Quinidine/tablet
Not less than 85 percent and not more than 110 percent of the labeled amount of the Quinidine Polygalacturonate shall dissolve in 30 minutes when tested using the USP Dissolution test (711) or equivalent method.
Shall meet the USP requirements for Weight Variation and Uniformity of Dosage (Content Uniformity) when tested using the USP method (905).
Not less than 32 months of the expiration dating period shall remain at time of delivery to the Government.
Workmanship. Tablets shall be free from defects which detract from their appearance or impair their serviceability.
Unit. Bottle (BT). One bottle containing 500 tablets, as specified, constitutes one unit.
DISTRIBUTION STATEMENT A. Approved for public release; distribution is unlimited.
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