Description

Salbutamol Hemisulfate is a high-purity active pharmaceutical ingredient (API) and a key salt form of the widely used bronchodilator, salbutamol. This compound is critical for ensuring the stability, efficacy, and precise dosing of respiratory medications. It is primarily utilized by pharmaceutical manufacturers in the development and production of inhalation solutions, metered-dose inhalers (MDIs), and dry powder inhalers (DPIs) for the treatment of asthma, chronic obstructive pulmonary disease (COPD), and other bronchospastic conditions.

Application

• Pharmaceutical API: Primary active ingredient in bronchodilator formulations for respiratory therapies.
• Inhalation Solutions: Used in nebulizer solutions for acute and chronic asthma management.
• Metered-Dose Inhalers (MDIs): A core component in pressurized aerosol inhalers for rapid relief of bronchoconstriction.
• Dry Powder Inhalers (DPIs): Formulated into micronized powder blends for breath-activated drug delivery systems.
• Research & Development: Serves as a reference standard and starting material in pharmacological research and new drug development.
• Veterinary Medicine: Employed in veterinary pharmaceuticals for the treatment of respiratory conditions in animals.

Basic Information

Product Name	Salbutamol Hemisulfate
CAS No.	36519-31-0
Molecular Formula	C26H44N2O10S
Molecular Weight	576.70 g/mol
Synonyms	Albuterol Hemisulfate; Salbutamol Sulfate (1:0.5); Albuterol Sulfate (hemihydrate basis); (RS)-Salbutamol Hemisulfate; 2-(tert-Butylamino)-1-(4-hydroxy-3-hydroxymethylphenyl)ethanol hemisulfate salt; Ventolin Hemisulfate; Aironir; Salbutamol 1/2 Sulfate
EINECS	Contact for details

Quality Control

Our Salbutamol Hemisulfate is manufactured under strict quality systems, with specifications designed to meet or exceed major pharmacopoeial standards such as USP, EP, and BP. Every batch undergoes comprehensive analytical testing including identification, assay, impurity profiling, and residual solvent analysis. Certificates of Analysis (COA) documenting full compliance with release specifications are provided and available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry, and well-ventilated area at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept under conditions that minimize exposure to atmospheric humidity.

Specification

Item	Specification
Appearance	White or almost white, crystalline powder
Identification (IR)	Conforms to standard
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	NMT 0.5%
Related Substances (HPLC)	Total impurities: NMT 1.0% Any individual impurity: NMT 0.5%
Residue on Ignition	NMT 0.1%
Heavy Metals	NMT 20 ppm
Specific Rotation	-0.10° to +0.10° (c = 2 in water)
pH (5% solution)	3.5 - 5.0

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