General Information

Salbutamol Impurities and Salbutamol 

Daicel Pharma synthesizes high-quality Salbutamol impurities like 5-Formyl salicyl alcohol, 5-Hydroxy Salbutamol, Salbutamol EP Imp-C Tertiary butyl amine salt, Salbutamol EP Impurity K, Salbutamol Head, and tail dimer, Salbutamol Impurity L, Salbutamol impurity O, and Salbutamol Impurity P, which are crucial in the analysis of the quality, stability, and biological safety of the active pharmaceutical ingredient Salbutamol. Moreover, Daicel Pharma offers custom synthesis of Salbutamol impurities and delivers them globally.

Salbutamol [CAS: 18559-94-9] is a selective, short-acting beta2-adrenergic receptor agonist. Its commonly used to manage bronchospasm in patients with asthma or chronic obstructive pulmonary disease (COPD).

Salbutamol: Use and Commercial Availability 

Salbutamol is used to relieve and prevent bronchospasm caused by conditions like bronchial asthma, chronic bronchitis, and other chronic bronchopulmonary disorders that involve bronchospasm. It is for acute prophylaxis against bronchospasm caused by exercise or other stimuli. The medicine is available under brand names such as Ventolin, Aerolin, or Ventorlin.

Salbutamol Structure and Mechanism of Action

The chemical name of Salbutamol is α¹-[(tert-butylamino)methyl]-4-hydroxy- m-Xylene-α,α′-diol. Its chemical formula is C₁₃H₂₁NO₃, and its molecular weight is approximately 239.31 g/mol.

Salbutamol relaxes bronchial smooth muscle as it acts on beta-2 adrenergic receptors.

Salbutamol Impurities and Synthesis

During the manufacturing¹ of Salbutamol, impurities form due to several factors, such as reaction conditions, the quality of starting materials, and the purification methods. These impurities may be hazardous and need diligent monitoring and control to ensure the safety and efficacy of the final product. Implementation of stringent quality control measures is necessary throughout production.

Daicel provides a Certificate of Analysis (CoA) for Salbutamol impurity standards, including 5-Formyl salicyl alcohol, 5-Hydroxy Salbutamol, Salbutamol EP Imp-C Tertiary butyl amine salt, Salbutamol EP Impurity K, Salbutamol Head and tail dimer, Salbutamol Impurity L, Salbutamol impurity O, and Salbutamol Impurity P. The CoA is issued from a cGMP-compliant analytical facility and contains complete characterization data, such as 1H NMR, 13C NMR, IR, MASS, and HPLC purity^2,3. Additional characterization data, such as 13C-DEPT and CHN, can be provided upon request. Daicel can also prepare any unknown Salbutamol impurity or degradation product. We give a complete characterization report on delivery.