Description

(R)-Darifenacin-D4 is a deuterated isotopologue of the active pharmaceutical ingredient darifenacin, specifically labeled at four positions with the stable isotope deuterium. This high-purity compound is a critical reference standard and an indispensable tool for advanced pharmaceutical research and development. It is primarily utilized by analytical chemists and researchers in the pharmaceutical industry for applications such as quantitative bioanalysis, metabolism studies, and method validation.

Application

• Pharmacokinetic and Metabolism Studies: Used as an internal standard in LC-MS/MS for the accurate quantification of darifenacin in biological matrices.
• Drug Development Research: Serves as a stable isotope-labeled tracer to investigate the absorption, distribution, metabolism, and excretion (ADME) profile of darifenacin.
• Analytical Method Validation: Essential for developing and validating highly sensitive and specific bioanalytical methods in compliance with GLP and FDA/EMA guidelines.
• Impurity Profiling and Characterization: Aids in the identification and structural elucidation of metabolites or degradation products.
• Clinical Research: Supports clinical trial studies requiring precise measurement of drug concentrations in plasma or urine.

Basic Information

Product Name	(R)-Darifenacin-D4
CAS No.	1261734-81-9
Molecular Formula	C28H30D4N2O2
Molecular Weight	426.61 g/mol
Synonyms	(3R)-1-[2-(2,3-Dihydro-5-benzofuranyl)ethyl]-α,α-diphenyl-3-pyrrolidineacetamide-d4; Darifenacin-d4; (R)-Darifenacin (tetradeuterated); Enablex-d4; 3-(R)-(1-[2-(2,3-dihydro-5-benzofuranyl)ethyl]-3-pyrrolidinyl)-2,2-diphenylacetamide-d4; Deuterated Darifenacin; Darifenacin Internal Standard; Darifenacin Isotopic Label
EINECS	Contact for details

Quality Control

Every batch of (R)-Darifenacin-D4 is manufactured under strict quality management systems and undergoes comprehensive analytical testing. We guarantee high chemical and isotopic purity, with specifications tailored for use as a certified reference material. A detailed Certificate of Analysis (COA) is provided with each shipment, documenting identity, purity (by HPLC), isotopic enrichment, and other critical parameters to ensure compliance with your research requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. This product is hygroscopic (moisture-sensitive) and should be kept in a dry environment. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Purity (D-enrichment)	≥ 98 atom % D
Chemical Purity (NMR)	Conforms
Residual Solvents (GC)	Meets ICH guidelines
Water Content (KF)	≤ 0.5%

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