Description

Salbutamol is a selective β2-adrenergic receptor agonist, a key active pharmaceutical ingredient (API) in the global pharmaceutical supply chain. Its primary value lies in its potent bronchodilator effect, making it essential for the formulation of respiratory medications. This compound is critically needed by pharmaceutical manufacturers producing treatments for asthma, chronic obstructive pulmonary disease (COPD), and other bronchospastic conditions.

Application

• Pharmaceutical API: Primary use as the active ingredient in metered-dose inhalers (MDIs), dry powder inhalers (DPIs), and nebulizer solutions for the treatment of asthma and COPD.
• Tablet Formulations: Used in the production of oral tablets for systemic bronchodilation.
• Syrup Formulations: Incorporated into pediatric and adult liquid oral dosage forms.
• Veterinary Medicine: Employed in veterinary pharmaceuticals for the management of respiratory conditions in animals.
• Research & Development: Serves as a reference standard and building block in pharmacological research and the development of new respiratory therapies.
• Contract Manufacturing: Supplied to CDMOs (Contract Development and Manufacturing Organizations) for the production of finished dosage forms.

Basic Information

Product Name	Salbutamol
CAS No.	35763-26-9
Molecular Formula	C13H21NO3
Molecular Weight	239.31 g/mol
Synonyms	Albuterol (USAN); Ventolin® (Trade Name); Salbutamol Sulfate; (RS)-4-[2-(tert-Butylamino)-1-hydroxyethyl]-2-(hydroxymethyl)phenol; AH-3365; Salbutamol Base
EINECS	252-703-6

Quality Control

Our Salbutamol is manufactured under strict quality management systems, targeting compliance with major pharmacopoeial standards including USP, EP, and BP. Every batch undergoes comprehensive analytical testing for identity, purity, and impurity profiles. A Certificate of Analysis (COA) detailing results for assay, related substances, residual solvents, and microbiological quality is provided with each shipment to ensure full traceability and regulatory support.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a low-humidity environment to prevent moisture absorption and degradation.

Specification

Item	Specification
Appearance	White or almost white crystalline powder
Identification (IR)	Conforms
Identification (HPLC)	Conforms to reference standard
Assay (on dried basis)	98.5% - 101.0%
Loss on Drying	≤ 0.5%
Related Substances (HPLC)	Individual impurity: ≤ 0.1% Total impurities: ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Sulfated Ash	≤ 0.1%
Heavy Metals	≤ 20 ppm
Microbiological Enumeration	Complies with EP/ USP

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.