Albuterol
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C13H21NO3 239.31

1,3-Benzenedimethanol,a1-[[(1,1-dimethylethyl)amino]methyl]-4-hydroxy-.
a1-[(tert-Butylamino)methyl]-4-hydroxy-m-xylene-a,a¢-diol [18559-94-9].
»Albuterol contains not less than 98.5percent and not more than 101.0percent of C13H21NO3,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.
Water,Method Iá921ñ: not more than 0.5%.
Residue on ignition á281ñ: not more than 0.1%.
Chromatographic purity—
Standard solution— Dissolve an accurately weighed quantity of USP Albuterol RSin methanol to obtain a solution having a known concentration of 0.10mg per mL.
Test solution— Dissolve an accurately weighed quantity of Albuterol in methanol to obtain a solution having a concentration of 20mg per mL.
Procedure— Apply 10-µLaliquots of the Test and the Standard solutionto separate points on a thin-layer chromatographic plate (see Chromatography á621ñ)coated with a 0.25-mm layer of chromatographic silica gel.Place the plate in a saturated chromatographic chamber,and develop the chromatogram in a solvent system consisting of a mixture of methyl isobutyl ketone,isopropyl alcohol,ethyl acetate,water,and ammonium hydroxide (50:45:35:18:3)until the solvent front has moved three-fourths of the length of the plate.Remove the plate from the developing chamber,air-dry,and expose it to iodine vapor:any spot,other than the principal spot,obtained from the Test solutionis not greater in size and intensity than the spot produced by the Standard solution(0.5%),and the sum of the impurities is not greater than 2.0%.
Assay— Dissolve about 400mg of Albuterol,accurately weighed,in 50mLof glacial acetic acid,add 2drops of crystal violet TS,and titrate with 0.1Nperchloric acid VS.Perform a blank determination,and make any necessary correction.Each mLof 0.1Nperchloric acid is equivalent to 23.93mg of C13H21NO3.
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 2505
Phone Number:1-301-816-8269