Levosalbutamol is a selective short-acting beta-2 adrenergic receptor agonist (SABA) used as a bronchodilator for the relief and prevention of reversible bronchospasm associated with obstructive airway conditions. It is the R-enantiomer of salbutamol (albuterol) and represents the pharmacologically active enantiomer responsible for the principal bronchodilatory activity of the racemic drug.
Levosalbutamol stimulates β2-adrenergic receptors in bronchial smooth muscle. Activation of these receptors increases intracellular cyclic AMP, producing relaxation of bronchial smooth muscle and resulting in bronchodilation.
Levosalbutamol is a synthetic small-molecule phenethylamine derivative with the molecular formula C13H21NO3 and a molecular weight of approximately 239.31 g/mol. The CAS Number of levosalbutamol is 34391-04-3.
The compound is commonly supplied in pharmaceutical products as levosalbutamol sulfate, particularly for inhalation and oral formulations.
Levosalbutamol selectively stimulates β2-adrenergic receptors in airway smooth muscle.
β2-receptor activation stimulates adenylate cyclase and increases intracellular cyclic AMP. This reduces bronchial smooth-muscle contraction and produces relaxation of the airways. The resulting bronchodilation helps improve airflow and relieve bronchospasm.
Levosalbutamol is used for the relief and prevention of bronchospasm associated with reversible obstructive airway diseases, including asthma and other conditions characterized by reversible airway narrowing.
It may be incorporated into pharmaceutical products such as metered-dose inhalers, nebulizer solutions, dry-powder inhalation products and oral formulations, depending on the approved product.
Levosalbutamol API can be evaluated using validated analytical procedures for identification, assay, related substances, enantiomeric purity, water content, residual solvents, elemental impurities and other applicable quality attributes.
Chromatographic methods such as HPLC may be used for assay and impurity determination. Because levosalbutamol is a specific enantiomer, appropriate control of stereochemical purity and the opposite enantiomer is an important quality attribute.
For inhalation products, additional controls may apply depending on the dosage form, including particulate matter, microbial quality, delivered dose and other inhalation-product specifications.
Levosalbutamol should be stored in a tightly closed pharmaceutical-grade container under controlled conditions. The material should be protected from excessive heat, moisture and direct light.
Specific storage and transportation conditions should follow the applicable manufacturer's approved specification.
Levosalbutamol API may be supplied for qualified pharmaceutical manufacturing, inhalation formulation development, analytical and research applications, subject to applicable quality and regulatory requirements.
Levosalbutamol API is available for qualified pharmaceutical development and manufacturing requirements subject to applicable quality and regulatory standards. Customers can request product specifications, Certificate of Analysis, analytical documentation, packaging information and commercial details according to their requirements.
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 1.0% |
| Heavy Metals | NMT 10 ppm |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 1.0% |
| Water Content | NMT 1.0% |