A-A-51388A
9 September 1986
SUPERSEDING
A-A-0051388 (DM)
2 April 1986
COMMERCIAL ITEM DESCRIPTION
MENOTROPINS FOR INJECTION, USP
The General Services Administration has authorized the use of this Commercial Item Description.
Salient Characteristics:
Shall be Menotropins for Injection, USP.
Shall be in accordance with the requirements of the USP.
Each ampul of hormone shall contain 75 I.U. of follicle-stimulating hormone and 75 I.U. of luteinizing hormone within the applicable assay limits for the injection.
Each ampul of Sodium Chloride Injection, USP, shall contain sufficient quantity of Sodium Chloride Injection, USP, for reconstitution.
Workmanship. Product shall be free from defects which detract from its appearance or impair its serviceability.
Unit. Package (PG). One package containing one ampul of hormone and one ampul of Sodium Chloride Injection, as specified, constitutes one unit.
Contractor certification. The contractor shall certify and maintain substantiating evidence that the product offered meets the salient characteristics of this Commercial Item Description, and that the product 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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