Salbutamol Sulphate

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Product Name :	Salbutamol Sulphate
Specs :	USP/BP/EP
Cas No.：	51022-70-9
Product Serie：	Other API
Product  Details ：	Molecular Formula: 2(C13H21NO3).H2SO4    Molecular Weight: 576.70

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Overview

With a molecular formula of C₁₃H₂₁NO₃·½H₂SO₄ and molecular weight of 343.42 g/mol, this white crystalline powder is the sulfate salt of salbutamol, a selective β₂-adrenergic receptor agonist. Developed to address respiratory disorders, it acts by relaxing bronchial smooth muscles, increasing airflow to the lungs, and alleviating symptoms of asthma and chronic obstructive pulmonary disease (COPD). Soluble in water and slightly soluble in ethanol, it is stable under normal storage conditions when protected from light and moisture, making it a cornerstone in both acute and maintenance therapy for reversible airway obstruction.

Features

1. Selective β₂-Receptor Affinity: Exhibits preferential binding to β₂-adrenergic receptors in bronchial tissues, minimizing cardiac stimulation (β₁-receptor interaction <1% at therapeutic doses), which reduces side effects like tachycardia compared to non-selective agonists.

2. Rapid Onset and Longevity: Inhaled formulations provide bronchodilation within 5-15 minutes, with effects lasting 4-6 hours, while oral tablets offer systemic action with a bioavailability of 50% due to first-pass metabolism, peaking plasma concentrations at 2-3 hours.

3. Multi-Formulation Versatility: Available in inhalers (MDIs, nebulizers), tablets, syrups, and injectables, catering to diverse patient needs—from acute asthma attacks (inhaled) to chronic management (oral). The sulfate salt form enhances water solubility, crucial for parenteral and liquid oral preparations.

4. Safety Profile: Well-tolerated with low toxicity (LD₅₀ >2000 mg/kg in rodents), though higher doses may cause tremors or hypokalemia. It is pregnancy category C (FDA), with limited transplacental passage, making it a cautious but frequently used option in maternal asthma.

5. Pharmacokinetic Stability: Metabolized primarily in the liver via sulfate conjugation and hydroxylation, with 75% excreted in urine as inactive metabolites. Its half-life of 3-4 hours allows flexible dosing schedules, and it does not accumulate in renal impairment, simplifying use in elderly or compromised patients.

Applications

• Respiratory Disorder Management:

◦ Acute Asthma: First-line treatment for bronchospasm, delivered via inhaled short-acting β₂-agonist (SABA) to relieve acute dyspnea, often paired with corticosteroids for anti-inflammatory synergy.

◦ COPD Maintenance: Oral or inhaled formulations improve exercise tolerance and reduce exacerbations by maintaining airway patency in chronic bronchitis/emphysema.

◦ Preterm Labor Prevention: Off-label use (in some regions) as a tocolytic agent, though debated due to maternal cardiovascular risks, leveraging β₂-receptor-mediated uterine smooth muscle relaxation.

• Veterinary Medicine: Used in equine and porcine species to treat respiratory distress, mirroring human applications with adjusted dosages.

• Research and Development: Serves as a reference standard for β₂-agonist assay development, and its structural analogs inspire new bronchodilator designs with improved selectivity or duration.

Quality Assurance

Manufactured under strict cGMP guidelines, our Salbutamol Sulphate meets BP, USP, and EP standards, with impurity profiles controlled to ≤0.1% for related substances. Particle size optimization (≤5μm for inhaled grades) ensures optimal lung deposition, and thermal analysis confirms a melting point of 180-185°C, guaranteeing batch-to-batch consistency.