A-A-53453 Potassium Chloride, L-Lysine Monohydrochloride, And Potassium Bicarbonate Tablets, Effervescent

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A-A-53453

Shall meet the requirements of the USP Weight Variation Test.

Shall contain a maximum of 0.2 percent moisture when determined by a suitable, accurate and reproducible method.

Workmanship. The tablets shall be free from defects which detract from their appearance or impair their serviceability.

Unit. Package (PG).

For Size 1, shall be supplied one tablet in a commercially available aluminum foil pocket, which shall be capable of maintaining the tablet moisture-free until opened. Each pocket shall be easily removed from the adjoining pocket without disturbing the seal of the adjoining pocket. One package containing 60 tablets, as specified, constitutes one unit.

For Size 2, shall be supplied one tablet in a commercially available aluminum foil pocket, which shall be capable of maintaining the tablet moisture-free until opened. Each pocket shall be easily removed from the adjoining pocket without disturbing the seal of the adjoining pocket. One package containing 1000 tablets, as specified, together with 33 polyethylene plastic bag suitable for dispensing the tablets, 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.

Regulatory requirements.

Federal Food, Drug and Cosmetic Act. If the product covered by this document has been determined by the U.S. Food and Drug Administration to be under its jurisdiction, the offeror/contractor shall comply, and be responsible for compliance by its subcontractors/suppliers, with the requirements of Federal Food, Drug and Cosmetic Act, as amended, and regulations promulgated thereunder. In addition, the offeror/contractor shall comply, and be responsible for compliance by its subcontractors/suppliers, with the requirements of all other applicable Federal, State, and local statutes, ordinances, and regulations.