Albuterol Sulfate
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This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition
Issued and maintained by the United States Pharmacopeial Convention (USP)
(C13H21NO3)2 · H2SO4 576.70
1,3-Benzenedimethanol, α1-[[(1,1-dimethylethyl)amino] methyl]-4-hydroxy-, sulfate (2:1) (salt).
α1-[(tert-Butylamino)methyl]-4-hydroxy-m-xylene-α,α′-diol sulfate (2:1) (salt) CAS RN®: 51022-70-9; UNII: 021SEF3731. » 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
4-[2-[(1,1-Dimethylethyl)amino]-1-hydroxyethyl]-2-methylphenol sulfate.
USP Albuterol Sulfate RS
1 Identication
Change to read:
A: Spectroscopic Identication Tests 〈197〉, Infrared Spectroscopy: 197K▲ (CN 1-May-2020) .
Change to read:
B: Spectroscopic Identication Tests 〈197〉, Ultraviolet-Visible Spectroscopy: 197U▲ (CN 1-May-2020) —
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 lter: the ltrate 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 Determination, 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 Organic Impurities 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 Sample solution.
2 Assay
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 ask, 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 ow 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.
