Description

(R)-Darifenacin Hydrobromide is the active pharmaceutical ingredient (API) and a key chiral intermediate for the synthesis of darifenacin, a potent muscarinic receptor antagonist. This high-purity enantiomer is critical for ensuring the efficacy and safety profile of the final drug product. It is primarily required by pharmaceutical manufacturers and advanced research institutions engaged in the development and production of urological medications for the treatment of overactive bladder (OAB).

Application

• Active Pharmaceutical Ingredient (API) for the manufacture of darifenacin-based medications.
• Chiral Building Block in advanced organic synthesis for muscarinic receptor-targeting compounds.
• Reference Standard for analytical method development and quality control in pharmaceutical laboratories.
• Process Development for optimizing enantioselective synthesis routes in R&D.
• Pharmacological Research for studying subtype-selective muscarinic receptor interactions.
• Formulation Development for creating controlled-release dosage forms.

Basic Information

Product Name	(R)-Darifenacin Hydrobromide
CAS No.	1092800-15-1
Molecular Formula	C28H30N2O2•HBr
Molecular Weight	507.47 g/mol
Synonyms	(3R)-1-[2-(2,3-Dihydro-5-benzofuranyl)ethyl]-α,α-diphenyl-3-pyrrolidineacetamide Hydrobromide; (R)-Darifenacin HBr; Darifenacin Related Compound R (Hydrobromide Salt); UNII-7K5C8VW8R8; (R)-3-(Diphenylacetyl)-1-(2-(2,3-dihydrobenzofuran-5-yl)ethyl)pyrrolidine Hydrobromide; (R)-Darifenacin Hydrobromide Salt; Enablex Impurity R (Hydrobromide)
EINECS	Contact for details

Quality Control

Our (R)-Darifenacin Hydrobromide is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including chiral purity verification, to ensure compliance with ICH guidelines and customer-specific requirements. A detailed Certificate of Analysis (COA) is provided with every shipment, confirming identity, purity, and impurity profiles.

Storage

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

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥98.5%
Chiral Purity (HPLC)	≥99.0%
Water Content (KF)	≤0.5%
Residue on Ignition	≤0.1%
Heavy Metals	≤20 ppm
Related Substances (HPLC)	Individual impurity ≤0.5%; Total impurities ≤1.0%

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