A-A-53529
17 June 1988
COMMERCIAL ITEM DESCRIPTION
ACETAZOLAMIDE CAPSULES
The General Services Administration has authorized the use of this Commercial Item Description.
Salient characteristics.
Shall be Acetazolamide Capsules.
Shall be sustained-release Acetazolamide Capsules 500 mg designed to be released over 12 hours using a method found acceptable to the FDA.
The capsules shall assay to contain not less than 90.0 percent and not more than 110.0 percent of the required amount of Acetazolamide when assayed by a suitable, accurate and reproducible method.
Material used in manufacture shall be of pharmaceutical grade.
Each capsule shall be marked/embossed with a product identification code to identify the active ingredient(s), strength, and manufacturer. The materials used in marking/embossing the dosage forms shall be acceptable to the FDA. The actual code used for the product shall be left to the discretion of the supplier.
Workmanship. The capsules shall be free from defects which detract from their appearance or impair their serviceability.
Unit. Bottle (BT). One bottle containing 100 capsules as specified, constitutes one unit.
DISTRIBUTION STATEMENT A. Approved for public release; distribution is unlimited.
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