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Albuterol Sulfate
(C13H21NO3)2·H2SO4 576.70

1,3-Benzenedimethanol, 1-[[(1,1-dimethylethyl)amino]methyl]-4-hydroxy-, sulfate (2:1) (salt).
1-[(tert-Butylamino)methyl]-4-hydroxy-m-xylene-,¢-diol sulfate (2:1) (salt) [51022-70-9].
» Albuterol Sulfate contains not less than 98.5 percent and not more than 101.0 percent of (C13H21NO3)2·H2SO4, calculated on the anhydrous basis.
Packaging and storage— Preserve in well-closed, light-resistant containers.
Identification—
Solution: 80 µg per mL.
Medium: 0.1 N hydrochloric acid.
C: Shake a quantity of it, equivalent to 4 mg of albuterol, with 10 mL of water, and filter: the filtrate so obtained responds to the tests for Sulfate 191.
Water, Method I 921: not more than 0.5%.
Residue on ignition 281: not more than 0.1%.
Chromatographic purity— It meets the requirements of the test for Chromatographic purity under Albuterol, except to read Albuterol Sulfate in place of Albuterol and to use water instead of methanol as the solvent to prepare the Standard solution and the Test solution.
Organic volatile impurities, Method I 467: meets the requirements.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Assay— Dissolve about 900 mg of Albuterol Sulfate, accurately weighed, in 50 mL of glacial acetic acid, add 2 drops of oracet blue B TS, and titrate with 0.1 N perchloric acid VS. Perform a blank determination, and make any necessary correction. Each 1 mL of 0.1 N perchloric acid is equivalent to 57.67 mg of (C13 H21NO3)2·H2SO4.
Auxiliary Information— Staff Liaison : Kahkashan Zaidi, Ph.D., Senior Scientific Associate
Expert Committee : (AER05) Aerosols05
USP29–NF24 Page 63
Pharmacopeial Forum : Volume No. 27(3) Page 2506
Phone Number : 1-301-816-8269