Description

Darifenacin Hydrobromide is a high-purity active pharmaceutical ingredient (API) and a selective muscarinic M3 receptor antagonist. This compound is critical for the development and manufacture of advanced pharmaceutical formulations targeting overactive bladder (OAB) syndrome. It is primarily required by pharmaceutical companies, research institutions, and contract development and manufacturing organizations (CDMOs) engaged in urological and neurological therapeutic areas.

Application

• Pharmaceutical API: Primary active ingredient in the manufacture of prescription medications for the treatment of overactive bladder (OAB).
• Drug Substance Intermediate: Used in the synthesis of final dosage forms such as extended-release tablets.
• Clinical Research Material: Serves as a reference standard and raw material for preclinical and clinical trial studies.
• Analytical Standard: Employed as a high-purity standard in HPLC, LC-MS, and other analytical methods for quality control and method validation.
• Formulation Development: Key component in R&D for developing new drug delivery systems and generic formulations.
• Contract Manufacturing: Supplied to CDMOs for the commercial-scale production of finished pharmaceutical products.

Basic Information

Product Name	Darifenacin Hydrobromide
CAS No.	133099-07-7
Molecular Formula	C28H30N2O2 • HBr
Molecular Weight	507.47 g/mol
Synonyms	Darifenacin HBr; UK-88,525; (2S)-1-[2-(2,3-Dihydro-5-benzofuranyl)ethyl]-α,α-diphenyl-3-pyrrolidineacetamide hydrobromide; 3-(S)-(-)-(1-[2-(2,3-dihydro-5-benzofuranyl)ethyl]-2-pyrrolidinylmethyl)-2,2-diphenylacetamide hydrobromide; Enablex (Brand Name); 1-[2-(2,3-dihydro-5-benzofuranyl)ethyl]-α,α-diphenyl-3-pyrrolidineacetamide monohydrobromide
EINECS	Contact for details

Quality Control

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

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Individual impurity: ≤ 0.5%; Total impurities: ≤ 2.0%
Optical Rotation	-20.0° to -24.0° (c=1 in methanol)

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