Description

Formoterol Fumarate Dihydrate is a selective β2-adrenergic receptor agonist used as a long-acting bronchodilator. This active pharmaceutical ingredient (API) is critical for the formulation of inhalation therapies designed to provide sustained relief for chronic respiratory conditions. It is primarily required by pharmaceutical manufacturers developing and producing metered-dose inhalers (MDIs), dry powder inhalers (DPIs), and nebulizer solutions for the treatment of asthma and chronic obstructive pulmonary disease (COPD).

Application

• Primary Active Pharmaceutical Ingredient (API) in long-acting bronchodilator medications.
• Formulation of metered-dose inhalers (MDIs) for asthma management.
• Manufacturing of dry powder inhalers (DPIs) for COPD treatment.
• Production of nebulizer solutions for hospital and clinical use.
• Key component in combination therapies with corticosteroids (e.g., budesonide/formoterol).
• Research and development of novel respiratory drug delivery systems.
• Reference standard for analytical testing and quality control in pharmaceutical labs.
• Starting material for the synthesis of related pharmaceutical compounds.

Basic Information

Item	Details
Product Name	Formoterol Fumarate Dihydrate
CAS No.	183814-30-4
Molecular Formula	C19H24N2O4 · C4H4O4 · 2H2O
Molecular Weight	492.51 g/mol
Synonyms	Formoterol Fumarate; Formoterol Fumarate Dihydrate; (R*,R*)-(±)-2'-Hydroxy-5'-((RS)-1-hydroxy-2-((RS)-p-methoxy-α-methylphenethylamino)ethyl)formanilide Fumarate Dihydrate; Eformoterol Fumarate Dihydrate; BD 40A; Foradil; Oxis; Atock; Perforomist; Arformoterol Tartrate related compound
EINECS	Contact for details

Quality Control

Our Formoterol Fumarate Dihydrate is manufactured under strict quality management systems. The product undergoes comprehensive analytical testing to ensure it meets high-purity pharmaceutical standards, including compliance with relevant pharmacopeial monographs (e.g., USP, EP). A detailed Certificate of Analysis (COA) is provided with each batch, confirming identity, purity, and impurity profiles.

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 dry environment to prevent moisture absorption.

Specification

Item	Specification
Appearance	White to almost white crystalline powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	6.0% - 8.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Heavy Metals	≤ 20 ppm
Specific Rotation	Contact for details
Microbial Limits	Complies with EP/USP <61> and <62>

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