SPL Set ID: c3fa0068-fd12-45de-818e-e929fb45ba05
1 drug(s) with this SPL Set ID
Albuterol tablets, USP contain 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: The molecular weight of albuterol sulfate is 576.71, and the molecular formula is (C 13 H 21 NO 3 ) 2 •H 2 SO 4 . Albuterol sulfate, USP is a white or practically white powder. It is freely soluble in water, slightly soluble in alcohol, in chloroform and in ether. The World Health Organization recommended name for albuterol base is salbutamol. Each albuterol tablet, USP for oral administration contains 2 mg or 4 mg of albuterol as 2.4 mg or 4.8 mg of albuterol sulfate, USP respectively and following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch (botanical source: maize) and sodium starch glycolate. FDA approved dissolution specification differs from the USP dissolution specification. Albuterol Tablet