A-A-0053612(DM)
29 August 1988
INTERIM COMMERCIAL ITEM DESCRIPTION
LEVOTHYROXINE SODIUM FOR INJECTION, LYOPHILIZED
The General Services Administration has authorized the use of this Interim Commercial Item Description which was developed by the Defense Personnel Support Center, Directorate of Medical Materiel, DPSC-RST, 2800 South 20th Street, Philadelphia, PA 19101, based upon currently available technical information.
Salient characteristics:
Shall be Levothyroxine Sodium for Injection, Lyophilized.
Shall be in accordance with the requirements of the FDA.
Shall contain the following ingredients wihtin the applicable assay limits:
Levothyroxine Sodium- 500.0 micrograms
Mannitol, USP- 10.0 mg
Tribasic Sodium Phosphate- 0.7 mg
(Anhydrous)
All ingredients entering into the manufacture of the product shall be of pharmaceutical grade.
Workamanship. The injection shall be free from defects which detract from its appearance or impair its serviceability.
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.
DISTRIBUTION STATEMENT A. Approved for public release; distribution is unlimited.
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