Albuterol

This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition

Issued and maintained by the United States Pharmacopeial Convention (USP)

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C₁₃H₂₁NO₃ 239.31 

1,3-Benzenedimethanol, α¹-[[(1,1-dimethylethyl)amino]methyl]-4-hydroxy-; 

α¹-[(tert-Butylamino)methyl]-4-hydroxy-m-xylene-α,α′-diol CAS RN^®: 18559-94-9; UNII: QF8SVZ843E. 

1 DEFINITION 

Albuterol contains NLT 98.5% and NMT 101.0% of albuterol (C₁₃H₂₁NO₃), calculated on the anhydrous basis.

2 IDENTIFICATION 

Change to read: 

A. Spectroscopic Identification Tests 〈197〉, Infrared Spectroscopy: 197K_{(CN 1-May-2020)} 

Change to read: 

B. Spectroscopic Identification Tests 〈197〉, Ultraviolet-Visible Spectroscopy: 197U_{(CN 1-May-2020)} 

Sample solution: 80 µg/mL in 0.1 N hydrochloric acid 

Acceptance criteria: Meets the requirements 

3 ASSAY 

Procedure 

Sample solution: 8 mg/mL of Albuterol in glacial acetic acid 

Analysis: To 50 mL of the Sample solution 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.

Acceptance criteria: 98.5%–101.0% on the anhydrous basis 

4 IMPURITIES 

Residue on Ignition 〈281〉: NMT 0.1% 

Organic Impurities 

Standard solution: 0.10 mg/mL of USP Albuterol RS in methanol 

Sample solution: 20 mg/mL of Albuterol in methanol 

4.1 Chromatographic system 

(See Chromatography 〈621〉, Thin-Layer Chromatography.) 

Mode: TLC 

Adsorbent: 0.25-mm layer of chromatographic silica gel 

Application volume: 10 µL 

Developing solvent system: Methyl isobutyl ketone, isopropyl alcohol, ethyl acetate, ammonium hydroxide, and water (50:45:35:3:18) Visualization: Iodine vapor 

4.2 Analysis 

Samples: Standard solution and Sample solution 

Proceed as directed in the chapter, applying aliquots of the Standard solution and the Sample solution. Develop in the Developing solvent system until the solvent front has moved three-fourths the length of the plate. Remove the plate from the developing chamber, air-dry, and expose it to iodine vapor. 

Acceptance criteria: Any spot, other than the principal spot, obtained from the Sample 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%. 

5 SPECIFIC TESTS 

Water Determination, Method I〈921〉: NMT 0.5% 

6 ADDITIONAL REQUIREMENTS 

Packaging and Storage: Preserve in well-closed, light-resistant containers. 

USP Reference Standards 〈11〉 

USP Albuterol RS