Description

Darifenacin is a highly selective muscarinic M3 receptor antagonist, a key active pharmaceutical ingredient (API) in the treatment of overactive bladder (OAB). Its precise mechanism of action provides effective relief from symptoms such as urinary urgency, frequency, and incontinence with a favorable side effect profile. This compound is essential for pharmaceutical manufacturers developing and producing advanced urological medications for the global healthcare market.

Application

• Primary Pharmaceutical Ingredient: As the core API in prescription medications for overactive bladder syndrome.
• Extended-Release Formulations: Used in the development and production of controlled-release tablets to ensure sustained therapeutic effect.
• Generic Drug Manufacturing: A critical component for companies producing bioequivalent versions of branded darifenacin medications.
• Clinical Research & Development: Serves as a reference standard and raw material in preclinical and clinical studies for new urological treatments.
• Drug Product Sourcing: Supplied to pharmaceutical companies for the commercial-scale synthesis of finished dosage forms.

Basic Information

Product Name	Darifenacin
CAS No.	133099-05-5
Molecular Formula	C28H30N2O2
Molecular Weight	426.55 g/mol
Synonyms	Darifenacin; UK-88,525; (2S)-1-[2-(2,3-Dihydro-5-benzofuranyl)ethyl]-α,α-diphenyl-3-pyrrolidineacetamide; (S)-2-{1-[2-(2,3-Dihydrobenzofuran-5-yl)ethyl]pyrrolidin-3-yl}-2,2-diphenylacetamide; Enablex (brand name); Emselex (brand name)
EINECS	Contact for details

Quality Control

Our Darifenacin is manufactured under strict quality management systems. We provide material that meets high-purity standards suitable for pharmaceutical applications, supported by comprehensive analytical documentation. A Certificate of Analysis (COA) is provided with each batch, detailing purity, identity, and impurity profiles to ensure compliance with your specifications.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (typically 15-25°C). Keep the container tightly sealed in a dry environment to maintain stability and prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time matches reference
Assay (HPLC)	≥ 98.5%
Related Substances (HPLC)	Total impurities ≤ 1.0% Any single impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Heavy Metals	≤ 20 ppm
Loss on Drying	≤ 0.5%

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