Albuterol Sulfate
(C13H21NO3)2·H2SO4 576.70

1,3-Benzenedimethanol,a1-[[(1,1-dimethylethyl)amino]methyl]-4-hydroxy-,sulfate (2:1)(salt).
a1-[(tert-Butylamino)methyl]-4-hydroxy-m-xylene-a,a¢-diol sulfate (2:1)(salt) [51022-70-9].
»Albuterol Sulfate contains not less than 98.5percent and not more than 101.0percent of (C13H21NO3)2·H2SO4,calculated on the anhydrous basis.
Packaging and storage— Preserve in well-closed,light-resistant containers.
Identification—
A: Infrared Absorption á197Kñ.
Solution: 80µg per mL.
Medium: 0.1Nhydrochloric acid.
C: Shake a quantity of it,equivalent to 4mg of albuterol,with 10mLof water,and filter:the filtrate so obtained responds to the tests for Sulfate á191ñ.
Water,Method Iá921ñ: not more than 0.5%.
Residue on ignition á281ñ: not more than 0.1%.
Chromatographic purity— It meets the requirements of the test for Chromatographic purityunder Albuterol,except to read Albuterol Sulfate in place of Albuterol and to use water instead of methanol as the solvent to prepare the Standard solutionand the Test solution.
Organic volatile impurities,Method Iá467ñ: meets the requirements.
Assay— Dissolve about 900mg of Albuterol Sulfate,accurately weighed,in 50mLof glacial acetic acid,add 2drops of oracet blue B TS,and titrate with 0.1Nperchloric acid VS.Perform a blank determination,and make any necessary correction.Each 1mLof 0.1Nperchloric acid is equivalent to 57.67mg of (C13H21NO3)2·H2SO4.
Auxiliary Information— Staff Liaison:Kahkashan Zaidi,Ph.D.,Senior Scientific Associate
Expert Committee:(AER)Aerosols
USP28–NF23Page 57
Pharmacopeial Forum:Volume No.27(3)Page 2506
Phone Number:1-301-816-8269
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