A-A-0051816A(DM)
The reconstituted solution shall have a pH between 5.0 and 9.0 and osmolality between 260 and 300 mosm/kg, when tested by a suitable, accurate and reproducible methods.
Materials used in the manufacture of the powder shall be of a pharmaceutical grade.
Workmanship. The powder shall be free from defects which detract from its appearance or impair its serviceability.
Unit.
For Type I, Container (CO). The container, (either a dispensing bottle or one or more packets with a dispensing bottle), containing 274 to 279 grams of powder, as specified, constitutes one unit. The dispensing bottle with a leak-proof cap shall have a capacity of not less than 4 liters of water, an indicator that denotes the final solution fill level, a suitable carrying handle and sufficient neck opening to allow for easy addition of the diluents and any powders.
For Type II, Bottle (BT), One bottle containing 278.26 g powder for reconstitution to 4 liters, 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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