Albuterol

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Cat Number

API0233265

CAS Number

18559-94-9

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Product Detail Description Scientific Support Customer Q&A

CAS Number

18559-94-9

EINECS

242-424-0

Synonyms

albuterol, Ventoline, Proventil HFA

Molecular Formula

C13H21NO3

Molecular Weight

239.3

Smiles

CC(C)(C)NCC(C1=CC(=C(C=C1)O)CO)O

Appearance

White to off-white crystalline powder

Melting Point

157-158℃

Boiling Point

433.5℃

General Description

Albuterol, known as salbutamol outside the United States, is a short-acting beta-2 adrenergic receptor agonist (SABA) that serves as a bronchodilator for reversible obstructive airway diseases. Initially FDA-approved in 1981, it is available in multiple formulations including metered-dose inhalers, nebulizer solutions, tablets, and syrup. As a rescue medication for acute bronchospasm, it remains the most widely prescribed short-acting beta-agonist worldwide.

Mechanism of Action

Albuterol produces bronchodilation by selectively activating beta-2 adrenergic receptors on airway smooth muscle, stimulating Gs-protein and adenylyl cyclase to increase intracellular cAMP. This activates protein kinase A, which phosphorylates myosin light chain kinase and inhibits its activity, preventing actin-myosin interaction and causing passive smooth muscle relaxation.

Application

Albuterol is indicated for treatment or prevention of bronchospasm in patients aged four years and older with reversible obstructive airway disease, and for prevention of exercise-induced bronchospasm. Standard dosing for acute symptoms is two inhalations every four to six hours, with onset of bronchodilation within 15 minutes and duration of three to four hours.

Chipps BE, et al. reported findings from a phase 3 double-blind trial that randomized 1,001 patients with mild-to-moderate asthma to evaluate whether both components contribute to the efficacy of an albuterol-budesonide combination pressurized metered-dose inhaler. Using a four-times-daily dosing regimen over 12 weeks, the study demonstrated that albuterol-budesonide 180/160 μg provided significantly greater bronchodilation (FEV₁ AUC₀–₆ₕ) compared to budesonide alone, confirming the contribution of albuterol. Both albuterol-budesonide doses (180/160 μg and 180/80 μg) produced significantly greater improvements in trough FEV₁ compared to albuterol alone, confirming the contribution of budesonide. The onset and duration of bronchodilation with the combination were similar to those observed with albuterol alone.

Fig. 1 Sequential testing of dual-primary end points. (Chipps BE, et al., 2023)

References

Chipps BE, et al. Albuterol-Budesonide Pressurized Metered Dose Inhaler in Patients With Mild-to-Moderate Asthma: Results of the DENALI Double-Blind Randomized Controlled Trial. Chest. 2023;164(3):585-595.

Does Albuterol require protection from light during storage?

Yes, it is photosensitive. Prolonged exposure to light can lead to degradation and discoloration. Store in light-resistant, well-closed containers in a cool, dry place.

What is the recommended storage temperature range for Albuterol?

Controlled room temperature, between 15°C and 25°C, is ideal. Avoid excessive heat, which can accelerate degradation, especially in the presence of moisture.

Is Albuterol susceptible to oxidation during long-term storage?

It can undergo oxidative degradation. Our packaging is designed to minimize headspace, and we recommend storing the material in its original container until use.

How is the impurity profile of Albuterol monitored for inhalation-grade quality?

We use a highly sensitive HPLC method to monitor related substances, including the albuterol-related impurity C, ensuring they meet strict pharmacopoeial limits for inhalation products.