A-A-51541A
26 August 1987
SUPERSEDING
A-A-0051541 (DM)
26 June 1986
COMMERCIAL ITEM DESCRIPTION
BENZTROPINE MESYLATE TABLETS, USP
The General Services Administration has authorized the use of this Commercial Item Description.
Salient characteristics:
Shall be Benztropine Mesylate Tablets, USP.
Shall be in accordance with the requirements of the USP.
Tablets shall contain 2 mg benztropine mesylate per tablet, within the applicable assayl limits for the tablets.
Materials used in the manufacturer of the tablets shall be of a pharmaceutical grade.
For Type I, the tablets must be considered by the FDA to be therapeutically equivalent with Benztropine Mesylate Tablets, USP, by Quantum Pharmics of the same dosage and administration schedule.
For Type II, the tablets must be considered by the FDA to be therapeutically equivalent with Benztropine Mesylate Tablets, USP, by Merck, Sharp, & Dohme at the same dosage and administration schedule.
Workmanship. The Tablets shall be free from defects which detract from its appearance or impair its serviceability.
Unit. Bottle (BT). One bottle containing 100 tablets, as specified, constitutes one unit.
Contractor certification. The contractor shall certify that the product offered meets the salient characteristics of this description and conforms to the producers’ own drawings, specifications, standards, and quality assurance practices. The Government reserves the right to require proof of such conformance prior to first delivery and thereafter as may be otherwise provided for under the provisions of the contract.
DISTRIBUTION STATEMENT A. Approved for public release; distribution is unlimited.
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