A-A-51527A
13 August 1987
SUPERSEDING
A-A-51527 (DM)
26 June 1986
COMMERCIAL ITEM DESCRIPTION
ISOPROTERENOL HYDROCHLORIDE INHALATION AEROSOL, USP
The General Services Administration has authorized the use of this Commercial Item Description as a replacement for MIL-I-37093 which is cancelled.
Salient characteristics:
Shall be Isoproterenol Hydrochloride Inhalation Aerosol, USP.
Shall be in accordance with the requirements of the USP.
Shall contain 0.25 percent (w/w) isoproterenol hydrochloride within the applicable assay limits for the aerosol.
Materials used in the manufacture of the product shall be of a pharmaceutical grade.
For Type 1, the aerosol must be considered by the FDA to be therapeutically equivalent to Isoproterenol Hydrochloride Inhalation Aerosol, USP, by the Winthrop-Breon Laboratories at the same dosage and administration schedule.
For Type 2, the aerosol must be considered by the FDA to be therapeutically equivalent to Isoproterenol Hydrochloride Inhalation Aerosol, USP, by the Winthrop-Breon Laboratories at the same dosage and administration schedule.
Shall be supplied 15 ml in a commercially available immediate container and shall deliver at least 300 single dose inhalations.
Workmanship. The Aerosol shall be free from defects which detract from its appearance or impair its serviceability.
Unit. Package (PG). One package containing one immediate container together with a detachable plastic mouthpiece with built-in nebulizer and protective cap, as specified, constitutes one unit.
DISTRIBUTION STATEMENT A. Approved for public release; distribution is unlimited.
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