A-A-0051719 (DM)
At the time of manufacture each vitamin shall assay to contain not less than 100.0 percent of its respective required amount, except for Riboflavin and Dexpanthenol which shall assay to contain not less than 90.0 percent of their respective required amounts when assayed as follows:
Each of the vitamins shall be assayed in accordance with approved NDA procedures or the respective USP method for “Decavitamin Capsules”, including any supplements or revisions thereto (may be modified to accommodate testing of vitamins in solution), except for Dexpanthenol which shall be assayed as follows:
Anal. Chem 21,823 (1949) and 23,1687 (1951) De Ritter, E. and Rubin, S.H. Make necessary sample changes in size and dilutions, as required, for all of the above vitamin assays.
Workmanship. The solution shall be free from defects which may detract from its appearance or impair its serviceability.
Unit. Package (PG). One package containing twenty-five two vial sets, 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.
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.
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