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TERBUTALINE SULFATE INJECTION USP
Vials
A sterile aqueous solution for subcutaneous injection
Rx Only
Prescribing Information
DESCRIPTION
Terbutaline sulfate USP, the active ingredient of terbutaline sulfate injection, is a beta-adrenergic agonist bronchodilator available as a sterile, nonpyrogenic, aqueous solution in vials, for subcutaneous administration. Each milliliter of solution contains 1 mg of terbutaline sulfate USP (0.82 mg of the free base), sodium chloride for isotonicity, and hydrochloric acid for adjustment to a target pH of 4. Terbutaline sulfate is (±)-α-[(tert -butylamino)methyl]-3,5-dihydroxybenzyI alcohol sulfate (2:1) (salt). The molecular formula is (C12H19N03)2•H2SO4 and the structural formula is:
Terbutaline sulfate USP is a white to gray-white crystalline powder. It is odorless or has a faint odor of acetic acid. It is soluble in water and in 0.1N hydrochloric acid, slightly soluble in methanol, and insoluble in chloroform. Its molecular weight is 548.65.
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