(al bue' ter ol sul' fate).
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.
USP Reference standards 11
USP Albuterol Related Compound A RS
B: Ultraviolet Absorption 197U
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 meets the requirements of the tests for Sulfate 191.
D: The retention time of the major peak in the chromatogram of the Assay preparation corresponds to that in the chromatogram of the Standard preparation, as obtained in the Assay.
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.
0.05 ± 0.01 M Ammonium acetate solution Dissolve 3.85 g of ammonium acetate in 1000 mL of water, and mix.
Mobile phase Prepare a degassed mixture of water, 0.05 ± 0.01 M Ammonium acetate solution, and isopropanol [65: 30: (5 ± 1)], and adjust dropwise with acetic acid to a pH of 4.5 ± 0.3.
Resolution solution Dissolve accurately weighed quantities of USP Albuterol Sulfate RS and USP Albuterol Related Compound A RS in water, and dilute quantitatively, and stepwise if necessary, with Mobile phase to obtain a solution having a known concentration of about 0.140 mg per mL and 0.030 mg per mL, respectively.
Standard preparation Dissolve an accurately weighed quantity of USP Albuterol Sulfate RS in water, and dilute quantitatively with water to obtain a solution having a known concentration of about 0.6 mg per mL.
Assay preparation Transfer about 60 mg of Albuterol Sulfate, accurately weighed, to a 100-mL volumetric flask, dissolve in and dilute with water to volume, and mix.
Chromatographic system (see Chromatography 621) The liquid chromatograph is equipped with a 276-nm detector and a 4.6-mm × 20-cm column that contains packing L10. The flow rate is about 2.0 mL per minute. Chromatograph the Resolution solution, and record the peak responses as directed for Procedure: the resolution, R, between albuterol and albuterol related compound A is not less than 1.5; and the relative standard deviation for replicate injections is not more than 1.5%.
Procedure Separately inject equal volumes (about 10 µL) of the Standard preparation and the Assay preparation into the chromatograph, record the chromatograms, and measure the responses for the major peaks. Calculate the quantity, in mg, of (C13H21NO3)2·H2SO4 in the portion of Albuterol Sulfate taken by the formula:
100C(rU / rS)in which C is the concentration, in mg per mL, of USP Albuterol Sulfate RS in the Standard preparation; and rU and rS are the peak responses obtained from the Assay preparation and the Standard preparation, respectively.
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USP35NF30 Page 2084Pharmacopeial Forum: Volume No. 34(2) Page 242