Albuterol Sulfate Syrup contains albuterol sulfate, USP, the racemic form of albuterol and a relatively selective beta 2-adrenergic bronchodilator. Albuterol sulfate has the chemical name α 1-[( tert-butylamino methyl]-4-hydroxy- m-xylene-α,α'-diol sulfate (2:1) (salt) and the following structural formula:
(C 13H 21NO 3) *H 2SO 4 M.W. 576.7
Albuterol sulfate is a white crystalline powder, soluble in water and slightly soluble in ethanol.
The World Health Organization recommended name for albuterol base is salbutamol.
Albuterol Sulfate Syrup for oral administration contains 2 mg of albuterol as 2.4 mg of albuterol sulfate in each teaspoonful (5 mL). Albuterol Sulfate Syrup also contains the inactive ingredients citric acid, FD&C Yellow #6, flavor enhancer, hypromellose, propylene glycol, purified water, sodium benzoate, sodium citrate, strawberry flavor. Sodium hydroxide may be added to adjust pH.
The pH of the syrup is 3.5 to 4.5.