A-A-53083A
The tablets shall have a 30 minute disintegration time, in simulated gastric fluid T.S. being used as the test medium, using the USP Method. As an alternate, shall have a 35 minute disintegration time (5 minutes in water at room temperature plus 30 minutes in gastric fluid at 37 degrees centigrade) using a suitable, accurate and reproducible method(s).
The tablets shall have a Dissolution Rate of NLT 85.0 percent in 30 minutes using 0. IN Hydrochloric Acid as the test medium and using the USP Rotating Basket, USP, Paddle Apparatus.
The tablets shall contain not more than 40 microbes per g when determined by a suitable, accurate, and reproducible method (s) acceptable to the FDA.
Each tablet shall be marked/embossed with a product identification code to identify the active ingredient (s), strength, 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 tablets shall be free from defects which detract from their appearance or impair their serviceability.
Unit.
For Size 1 – Bottle (BT). One bottle containing 100 tablets, as specified, constitutes one unit.
For Size 2 – Bottle (BT). One bottle containing 1000 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.
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