Salbutamol Impurities
Time:2025-04-15
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Salbutamol, a representative short-acting β2-adrenergic receptor agonist, was first developed and marketed by GlaxoSmithKline (GSK) in 1968. In 1993, GSK‘s Salbutamol Sulfate Injection (brand name: Ventolin) was approved in the UK. By 2003, GSK‘s Salbutamol Sulfate Inhalation Aerosol (Ventolin) entered the Chinese market。
By inhibiting histamine release and alleviating bronchospasm, Salbutamol has become a cornerstone in treating respiratory diseases such as asthma and chronic obstructive pulmonary disease (COPD), available in various formulations including inhalers, tablets, and injections. AstraZeneca‘s Budesonide/Salbutamol Sulfate Inhalation Aerosol (PT027), approved by the FDA in January 2023, initiated Phase III clinical trials in China in 2025. This marks the first combination therapy integrating anti-inflammatory and emergency relief functions.
Impurity control is critical to ensuring Salbutamol‘s clinical safety. Impurities may originate from synthesis processes, storage degradation, or packaging materials, and their potential toxicity must be mitigated through stringent quality control. The European Pharmacopoeia 11.0 edition explicitly lists specified impurities such as EP Impurity C, D, and F. The U.S. Pharmacopeia (USP) has introduced the "Pharmaceutical Analytical Impurities (PAI)" series, covering novel impurities like Didesoxy Salbutamol (CAS 132183-64-3) and O-Benzyl Salbutamol (CAS 56796-66-8).
SZEB provides a comprehensive portfolio of Salbutamol impurities, including EP/USP-compliant reference standards, process-related impurities, and degradation products, with custom synthesis services available. Visit www.ex-biotech.com or contact us at +86-0755-23051186 for the full impurity catalog and detailed services.
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