Description

2,3-Dehydro Darifenacin Hydrobromide is a key pharmaceutical intermediate and impurity standard used in the development and quality control of darifenacin, a medication for overactive bladder. This compound is critical for ensuring the purity, safety, and regulatory compliance of the final active pharmaceutical ingredient (API). It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions focused on urological therapeutics and advanced chemical synthesis.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for HPLC and LC-MS analysis in the quality control of Darifenacin Hydrobromide API.
• Process Chemistry Research: Used as a critical intermediate in route scouting and optimization for the synthesis of darifenacin and its analogs.
• Analytical Method Development: Essential for developing and validating stability-indicating methods to monitor degradation products in drug formulations.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity characterization data for drug master files.
• Academic & Biomedical Research: Utilized in pharmacological studies to understand the structure-activity relationship (SAR) of muscarinic receptor antagonists.
• Custom Synthesis Building Block: Acts as a specialized precursor for the synthesis of novel chemical entities in medicinal chemistry programs.

Basic Information

Product Name	2,3-Dehydro Darifenacin Hydrobromide
CAS No.	943034-52-4
Molecular Formula	C28H30N2O2 • HBr
Molecular Weight	507.47 g/mol
Synonyms	(3S)-1-[2-(2,3-Dihydro-5-benzofuranyl)ethyl]-α,α-diphenyl-3-pyrrolidineacetamide Hydrobromide; Darifenacin Impurity; Darifenacin Related Compound; 2,3-Dehydro Darifenacin HBr; UNII-7F9I6VK5VQ; (3S)-1-[2-(2,3-Dihydrobenzofuran-5-yl)ethyl]-α,α-diphenyl-3-pyrrolidineacetamide Hydrobromide
EINECS	Contact for details

Quality Control

Every batch of 2,3-Dehydro Darifenacin Hydrobromide is manufactured and tested under a strict quality management system. We provide comprehensive analytical data to ensure the material meets the high-purity standards required for pharmaceutical analysis and synthesis. A Certificate of Analysis (COA) detailing identity, purity (by HPLC), and impurity profile is supplied with each shipment to support your quality and regulatory requirements.

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 should be handled in a dry environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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