Salbutamol, also known as albuterol, is a short-acting selective β2-adrenergic receptor agonist widely used as a bronchodilator for the management of bronchospasm associated with asthma and chronic obstructive airway conditions. It is a member of the phenylethanolamine class and is available in pharmaceutical products primarily as salbutamol sulfate.
Salbutamol API is the active pharmaceutical ingredient used in oral, inhalation and other pharmaceutical formulations. The free-base substance has the molecular formula C13H21NO3 and molecular weight 239.31 g/mol. Its CAS number is 18559-94-9.
In the United States, the substance is commonly referred to as albuterol, while salbutamol is the WHO-recommended name. Pharmaceutical products frequently use the sulfate salt, salbutamol sulfate/albuterol sulfate, which has an empirical formula of (C13H21NO3)2·H2SO4 and molecular weight 576.7 g/mol.
Salbutamol is a phenylethanolamine derivative containing a phenolic hydroxyl group, hydroxymethyl functionality and a tert-butylamino substituent. The free base is identified by CAS 18559-94-9, while the sulfate salt is the commonly used pharmaceutical form.
Salbutamol is primarily used in medicines intended to relieve or prevent bronchospasm. It is used in formulations for asthma and other reversible obstructive airway disorders, including chronic obstructive pulmonary disease. WHO-listed pharmaceutical forms include inhalation aerosol, inhalation solution and certain injectable preparations as the sulfate salt.
Salbutamol selectively stimulates β2-adrenergic receptors in bronchial smooth muscle. This produces relaxation of the airway smooth muscle and results in bronchodilation, helping to relieve bronchospasm and improve airflow.
High-quality Salbutamol API manufacturing requires appropriate controls for identity, assay, related substances, residual solvents, water content, inorganic impurities and other applicable quality attributes. Salbutamol is recognized in pharmacopoeial contexts including USP and Ph. Eur., and analytical testing should follow the applicable current pharmacopoeial monograph and approved product specification.
| Property | Value |
|---|---|
| API Name | Salbutamol |
| Synonym | Albuterol |
| CAS No. | 18559-94-9 |
| Molecular Formula | C13H21NO3 |
| Molecular Weight | 239.31 g/mol |
| Drug Class | β2-Adrenergic Agonist |
| Therapeutic Class | Bronchodilator |
| Pharmaceutical Salt | Salbutamol Sulfate |
| Sulfate Molecular Weight | 576.7 g/mol |
The free-base molecular data are supported by PubChem, while the sulfate molecular weight and formula are stated in the current DailyMed labeling for albuterol sulfate.
Salbutamol API should be packaged in suitable pharmaceutical-grade containers that protect the material from contamination, moisture and environmental exposure. Storage conditions should follow the manufacturer's validated stability data and approved API specification.
Typical pharmaceutical API documentation may include:
A qualified Salbutamol API manufacturer in India should maintain appropriate pharmaceutical quality systems, validated analytical procedures, controlled manufacturing processes and traceable documentation. Salbutamol's established use as a bronchodilator and its availability in recognized pharmaceutical forms make reliable API quality, consistency and regulatory compliance important considerations for formulation development and commercial manufacturing.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |