Salbutamol Sulfate

Synonymes : 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.

Structure chimique et propriétés

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.

Mécanisme d'action

• β2-Adrenergic receptor agonism: Salbutamol binds to β2 receptors on bronchial smooth muscle cells, activating adenylate cyclase and increasing intracellular cAMP. This leads to relaxation of smooth muscle and bronchodilation.
• Inhibition of mediator release: Elevated cAMP reduces the release of histamine, leukotrienes, and other inflammatory mediators from mast cells and basophils.
• Mucociliary clearance enhancement: β2 agonism increases ciliary beat frequency, aiding in the clearance of mucus from the airways.
• Uterine relaxation: Off-target effects on β2 receptors in the uterus can cause relaxation, although this is not the primary therapeutic use.

Quality Specifications (QC Tests)

Approvisionnement et documentation

• Capacité: 5 metric tons per month
• Délai de livraison: 3-5 business days for stock items
• Documentation: COA, MSDS, TDS, stability data, and regulatory support available upon request
• Emballage: 25 kg fiber drum with double polyethylene liner; custom packaging options available

Foire aux questions

What is the minimum order quantity (MOQ) for Salbutamol Sulfate?

Our standard MOQ is 1 kg. For larger quantities, we offer competitive pricing and flexible delivery schedules.

How long does delivery take?

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.

Do you provide a Certificate of Analysis (COA) and samples?

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.

What are the storage conditions?

Store in a cool, dry place away from direct sunlight. Keep container tightly closed when not in use.

Contact & Ordering Information

• Company: LyvBio Co., Ltd.
• Address: Room 5-0203, Courtyard 205, Lianhu District, Xi’an, Shaanxi, China
• Email: info@lyvbio.com
• Phone: +86-29-65816888

send us your specification for a quotation.