Description

Flutropium Bromide is a high-purity, synthetic quaternary ammonium anticholinergic agent. It serves as a critical pharmaceutical intermediate in the development of long-acting muscarinic antagonist (LAMA) medications for respiratory conditions. This compound is essential for manufacturers in the global pharmaceutical and fine chemical industries engaged in the synthesis of advanced inhalation therapies. Consistent quality and reliable supply are paramount for ensuring the efficacy and safety of the final active pharmaceutical ingredients (APIs).

Application

• Pharmaceutical Intermediate: Primary use in the synthesis of Flutropium Bromide API for inhalation solutions and powders.
• Respiratory Drug Development: Key building block for research and production of bronchodilators used in chronic obstructive pulmonary disease (COPD) and asthma management.
• Fine Chemical Synthesis: Used in advanced organic synthesis for introducing the tropane alkaloid structure with a fluorinated side chain.
• Reference Standard: Serves as an analytical standard in quality control laboratories for method development and validation.
• Clinical Research Materials: Supplied for preclinical and clinical trial material (CTM) manufacturing under GMP guidelines.
• Contract Manufacturing: Sourced by CDMOs (Contract Development and Manufacturing Organizations) for proprietary client formulations.

Basic Information

Product Name	Flutropium Bromide
CAS No.	63516-07-4
Molecular Formula	C19H25BrFNO3
Molecular Weight	414.31 g/mol
Synonyms	(8r)-8-(2-fluoroethyl)-3-[(hydroxydiphenylacetyl)oxy]-8-methyl-8-azoniabicyclo[3.2.1]octane bromide; Flutropium bromide (USAN); UNII-8V32U4F5JN; 8-(2-Fluoroethyl)-3-[(hydroxydiphenylacetyl)oxy]-8-methyl-8-azoniabicyclo[3.2.1]octane bromide; Tropanol, 8-(2-fluoroethyl)-3-(hydroxydiphenylacetate)-8-methyl-, bromide (1:1), (3-endo)-; BA 598BR; LAMA intermediate
EINECS	Contact for details

Quality Control

Our Flutropium Bromide is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing to ensure it meets stringent specifications for pharmaceutical intermediate use. We provide full traceability and support regulatory filings with detailed documentation. Certificates of Analysis (COA) are available upon request, confirming identity, purity, and impurity profiles as per client requirements.

Storage

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

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	≥98.0% (on anhydrous basis)
Water Content (KF)	≤2.0%
Related Substances (HPLC)	Total impurities ≤2.0%; Any single impurity ≤0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Heavy Metals	≤20 ppm

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