Description

(±)-Darifenacin CAS NO 133033-93-9 is a racemic mixture of the antimuscarinic agent Darifenacin, a compound of significant interest in pharmaceutical research and development. It serves as a crucial intermediate and reference standard for the synthesis and analytical validation of the active enantiomer used in therapeutic applications. This product is essential for pharmaceutical manufacturers, contract research organizations (CROs), and academic institutions engaged in the development of urological and overactive bladder (OAB) treatments, as well as for quality control and method development laboratories.

Application

• Pharmaceutical Intermediate: Key starting material or synthetic precursor in the production of Darifenacin hydrobromide, the active pharmaceutical ingredient (API).
• Reference Standard: Used in analytical method development, validation, and quality control (QC) testing to ensure the purity and identity of final drug products.
• Pharmacological Research: Employed in preclinical studies to investigate the mechanism of action, metabolism, and structure-activity relationships (SAR) of muscarinic receptor antagonists.
• Impurity Profiling: Serves as a critical standard for identifying and quantifying related substances and degradation products in API and finished dosage forms.
• Process Development & Optimization: Utilized in scaling up and optimizing synthetic routes within process chemistry and manufacturing science (MS&T) teams.
• Regulatory Submissions: Provides essential data and characterization support for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).

Basic Information

Product Name	(±)-Darifenacin
CAS No.	133033-93-9
Molecular Formula	C28H30N2O2
Molecular Weight	426.55 g/mol
Synonyms	Darifenacin Racemate; 3-(S)-1-[2-(2,3-Dihydro-5-benzofuranyl)ethyl]-2,5-pyrrolidinedione; 2,3-Dihydro-5-[2-[1-(phenylmethyl)-3-pyrrolidinyl]ethyl]-1-benzofuran-7-carboxylic Acid Methyl Ester; UCB-2028-1; UK-88,525 Racemate; 7-Carbomethoxy-2,3-dihydro-5-[2-[1-(phenylmethyl)-3-pyrrolidinyl]ethyl]benzofuran
EINECS	Contact for details

Quality Control

Our (±)-Darifenacin is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including identification, assay, and impurity profiling via advanced techniques like HPLC and GC, to ensure it meets stringent specifications for pharmaceutical use. Certificates of Analysis (COA) detailing all test results are provided and can be tailored to support specific regulatory requirements, including ICH Q3A/B guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry, well-ventilated area. Keep the container sealed to protect the product from moisture.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Loss on Drying	≤ 0.5%

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