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C13H21NO3 239.31

1,3-Benzenedimethanol, 1-[[(1,1-dimethylethyl)amino]methyl]-4-hydroxy-.
1-[(tert-Butylamino)methyl]-4-hydroxy-m-xylene-,¢-diol [18559-94-9].
» Albuterol contains not less than 98.5 percent and not more than 101.0 percent of C13H21NO3, calculated on the anhydrous basis.
Packaging and storage— Preserve in well-closed, light-resistant containers.
Solution: 80 µg per mL.
Medium: 0.1 N hydrochloric acid.
Water, Method I 921: not more than 0.5%.
Residue on ignition 281: not more than 0.1%.
Chromatographic purity—
Standard solution— Dissolve an accurately weighed quantity of USP Albuterol RS in methanol to obtain a solution having a known concentration of 0.10 mg per mL.
Test solution— Dissolve an accurately weighed quantity of Albuterol in methanol to obtain a solution having a concentration of 20 mg per mL.
Procedure— Apply 10-µL aliquots of the Test and the Standard solution to separate points on a thin-layer chromatographic plate (see Chromatography 621) 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 solution is 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 400 mg of Albuterol, accurately weighed, in 50 mL of glacial acetic acid, add 2 drops of crystal violet TS, and titrate with 0.1 N perchloric acid VS. Perform a blank determination, and make any necessary correction. Each mL of 0.1 N perchloric acid is equivalent to 23.93 mg of C13H21NO3.
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Topic/Question Contact Expert Committee
Monograph Kahkashan Zaidi, Ph.D.
Senior Scientist
(AER05) Aerosols05
Reference Standards Lili Wang, Technical Services Scientist
USP32–NF27 Page 1437
Pharmacopeial Forum: Volume No. 27(3) Page 2505