Salbutamol Sulfate
| Parameter | Specification |
|---|---|
| Product Name | Salbutamol Sulfate |
| CAS Number | 51022-70-9 |
| Molecular Formula | C13H21NO3·1/2H2SO4 |
| Molecular Weight | 288.34 g/mol (as sulfate salt) |
| Appearance | White to off-white crystalline powder |
| Assay (HPLC) | 98.5% – 101.0% (on dried basis) |
| Solubility | Soluble in water, slightly soluble in ethanol, practically insoluble in chloroform |
| Particle Size | 98% through 100 mesh |
| Package | 25 kg fiber drum with double polyethylene liner |
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Synonyms: Albuterol sulfate, α-[(tert-Butylamino)methyl]-4-hydroxy-m-xylene-α,α’-diol sulfate, Salbutamol hemisulfate, 51022-70-9, Ventolin, Proventil, Salbutamol sulfate API
Salbutamol sulfate is a short-acting β2-adrenergic receptor agonist that belongs to the phenylaminoethanol class. Its molecular architecture features a resorcinol core with a hydroxymethyl group and a tert-butylamino side chain, which confers high selectivity for β2 receptors over β1. The sulfate salt form (hemisulfate) enhances aqueous solubility and stability, making it suitable for inhalation and oral dosage forms. The compound acts by relaxing bronchial smooth muscle, thereby relieving bronchospasm in conditions such as asthma and COPD.
Manufactured through a multi-step synthesis starting from 2,4-dihydroxyacetophenone, salbutamol sulfate is produced under cGMP conditions. The process involves selective bromination, condensation with tert-butylamine, and reduction to yield the active moiety, followed by salt formation with sulfuric acid. The resulting API is a white to off-white crystalline powder, freely soluble in water, and is standardized to 98.5–101.0% assay on the dried basis. It is available in various particle sizes to meet formulation requirements for metered-dose inhalers, dry powder inhalers, and oral solid dosage forms.
As a frontline bronchodilator, salbutamol sulfate remains essential in respiratory medicine. Its rapid onset (within 5 minutes via inhalation) and duration of action (4–6 hours) make it the drug of choice for acute asthma attacks. In the pharmaceutical industry, it is widely used in inhalation aerosols, nebulizer solutions, tablets, and syrups. The API is also employed as a reference standard in analytical laboratories and as a research tool to study β2-adrenergic signaling pathways.
Salbutamol sulfate is the hemisulfate salt of salbutamol, with a molecular formula of C13H21NO3·1/2H2SO4 and a molecular weight of 288.34 g/mol. The free base has a molecular weight of 239.31 g/mol. The sulfate salt is more stable and water-soluble than the free base, with a solubility of approximately 10 mg/mL in water at 25°C. The compound is optically active due to the presence of a chiral center at the benzylic carbon; the commercial product is a racemic mixture. It is sensitive to light and moisture, and should be stored in airtight containers away from direct sunlight.
| Test Item | Specification |
|---|---|
| Identification | IR spectrum conforms to reference standard; UV λmax at 276 nm |
| Loss on Drying | ≤ 0.5% |
| Residue on Ignition | ≤ 0.1% |
| Heavy Metals | ≤ 20 ppm |
| Related Substances | Any individual impurity ≤ 0.5%; total impurities ≤ 1.0% |
| Microbial Limits | Total aerobic count ≤ 1000 CFU/g; Yeast & mold ≤ 100 CFU/g; E. coli absent |
Our standard MOQ is 1 kg. For larger quantities, we offer competitive pricing and flexible delivery schedules.
For stock items, delivery is typically 3-5 business days from order confirmation. We ship globally via air or sea freight, depending on your location and preferences.
Yes, we provide a COA for each batch. Samples of 10-20 g are available free of charge for quality evaluation, though shipping costs may apply.
Store in a cool, dry place away from direct sunlight. Keep container tightly closed when not in use.
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