Description

Rac Darifenacin-D4 CAS NO 1189701-43-6 is a deuterated isotopologue of the muscarinic receptor antagonist darifenacin, specifically designed for use as an internal standard in quantitative analytical methods. This high-purity reference material is critical for ensuring the accuracy and reliability of pharmacokinetic and metabolic studies, as it compensates for matrix effects and instrument variability. It is an essential tool for pharmaceutical R&D laboratories, contract research organizations (CROs), and quality control units engaged in the development and bioanalysis of darifenacin and related therapeutic agents.

Application

• Internal Standard for LC-MS/MS: Primary application as a stable, isotopically labeled internal standard for the precise quantification of darifenacin in biological matrices (plasma, urine, tissue) using liquid chromatography-tandem mass spectrometry.
• Pharmacokinetic & Metabolism Studies: Enables accurate tracking of absorption, distribution, metabolism, and excretion (ADME) profiles of darifenacin in preclinical and clinical research.
• Bioanalytical Method Development & Validation: Serves as a critical component in developing, optimizing, and validating robust analytical methods compliant with FDA, EMA, and ICH guidelines.
• Drug Impurity Profiling: Used as a reference marker in stability studies and impurity characterization to understand degradation pathways of darifenacin formulations.
• Isotope Dilution Mass Spectrometry (IDMS): Employed in high-accuracy IDMS techniques for definitive method development and certified reference material characterization.

Basic Information

Item	Detail
Product Name	Rac Darifenacin-D4
CAS No.	1189701-43-6
Molecular Formula	C28H27D4NO3
Molecular Weight	Approx. 426.57 g/mol
Synonyms	Darifenacin-d4; (3S)-1-[2-(2,3-Dihydro-5-benzofuranyl)ethyl]-α,α-diphenyl-3-pyrrolidineacetamide-d4; rac-Darifenacin-d4; Darifenacin (deuterated); Darifenacin Internal Standard; 1189701-43-6; UNII-Not Assigned
EINECS	Contact for details

Quality Control

Every batch of Rac Darifenacin-D4 is manufactured and analyzed under strict quality management systems. We provide comprehensive analytical data to support its use in regulated environments. The product is characterized by advanced spectroscopic and chromatographic techniques, including NMR, MS, and HPLC, to confirm structure, isotopic enrichment (typically ≥98% D), and chemical purity. A detailed Certificate of Analysis (COA) is supplied with each shipment, documenting batch-specific results for identity, assay, purity, and residual solvents.

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 material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability. 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.