A-A-51611
8 July 1987
COMMERCIAL ITEM DESCRIPTION
METHYLPREDNISOLONE ACETATE SUSPENSION, STERILE, USP
The General Services Administration has authorized the use of this Commercial Item Description.
Salient Characteristics:
Shall be Methylprednisolone Acetate Suspension, Sterile, USP.
Shall be in accordance with the requirements of the USP.
All ingredients used in the manufacture of the suspension shall be of pharmaceutical grade.
Shall contain 40 mg methylprednisolone acetate per ml, within the applicable assay limits for the suspension.
For Type I, the suspension must be considered by the FDA to be therapeutically equivalent to Methylprednisolone Acetate Suspension, Sterile, USP, by Steris Laboratories at the same dosage and administration schedule.
For Type II, the suspension must be considered by the FDA to be therapeutically equivalent Methylprednisolone Acetate Suspension, Sterile, USP, by Steris Laboratories, Inc, at the same dosage and administration schedule.
Workmanship. The suspension shall be free from defects which detract from its appearance or impair its serviceability.
Unit. Vial (VI).
For Size 1, one multiple-dose vial containing 1 ml, as specified, constitutes one unit.
For Size 2, one multiple-dose vial containing 5 ml, as specified, constitutes one unit.
DISTRIBUTION STATEMENT A. Approved for public release; distribution is unlimited.
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