Description

Berodual is a pharmaceutical-grade combination product primarily used as a bronchodilator in respiratory therapy. Its value lies in providing a synergistic therapeutic effect for managing obstructive airway diseases, offering rapid and effective relief. This product is essential for manufacturers in the global pharmaceutical industry developing inhalation solutions, metered-dose inhalers (MDIs), and dry powder inhalers (DPIs).

Application

• Active Pharmaceutical Ingredient (API) in metered-dose inhalers (MDIs) for asthma and COPD treatment.
• Formulation component for nebulizer solutions used in hospital and home-care settings.
• Key ingredient in the development of dry powder inhaler (DPI) formulations.
• Used in clinical research and generic pharmaceutical development for respiratory drugs.
• Reference standard in analytical laboratories for quality control and method validation.

Basic Information

Product Name	Berodual
CAS No.	115112-73-7
Molecular Formula	C13H18BrNO4 • C12H18N2O • H2O
Molecular Weight	594.44 g/mol (as monohydrate)
Synonyms	Fenoterol Hydrobromide and Ipratropium Bromide Combination; Ipratropium Bromide and Fenoterol Hydrobromide; Ipratropium/Fenoterol; Duovent; Combivent (similar combination); Bronchodilator Combination; (R,R)-Fenoterol hydrobromide - (1R,3r,5S,8r)-3-(3-Hydroxy-1-oxo-2-phenylpropoxy)-8-methyl-8-(1-methylethyl)-8-azoniabicyclo[3.2.1]octane bromide (1:1:1) monohydrate
EINECS	Contact for details

Quality Control

Our Berodual is manufactured under strict quality systems to meet the rigorous standards of the pharmaceutical industry. Each batch is tested to confirm identity, potency, purity, and the absence of specified impurities, aligning with pharmacopeial guidelines. A comprehensive Certificate of Analysis (COA) documenting all test results is provided with every shipment to ensure full traceability and compliance.

Storage

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

Specification

Item	Specification
Appearance	White or almost white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	NMT 5.0%
Related Substances (HPLC)	Total impurities: NMT 2.0% Any individual impurity: NMT 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Heavy Metals	NMT 20 ppm
Microbial Enumeration	Complies with Ph. Eur. 2.6.12/2.6.13

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