Description

(R)-Darifenacin-D4 Hydrobromide is a deuterated, high-purity reference standard of the active pharmaceutical ingredient darifenacin. This compound is specifically designed for use in advanced analytical and research applications where precise quantification and metabolic pathway elucidation are critical. It is an essential tool for pharmaceutical R&D, bioanalytical method development, and quality control laboratories requiring the highest standards of accuracy and traceability.

Application

• Pharmaceutical Reference Standard: Serves as a certified internal standard for the precise quantification of darifenacin and its metabolites in complex biological matrices using LC-MS/MS and HPLC methods.
• Drug Metabolism and Pharmacokinetics (DMPK) Studies: Enables accurate tracking and analysis of metabolic pathways, absorption, distribution, and excretion profiles in preclinical and clinical research.
• Bioanalytical Method Development and Validation: Critical for developing robust, sensitive, and specific assays for therapeutic drug monitoring and regulatory submissions.
• Impurity Profiling and Characterization: Used to identify and quantify process-related impurities and degradants in active pharmaceutical ingredient (API) batches.
• Stability-Indicating Assays: Supports studies to determine the shelf-life and degradation patterns of pharmaceutical formulations under various conditions.
• Clinical Research: Facilitates accurate pharmacokinetic analysis in human trials for drugs targeting muscarinic receptors, such as those for overactive bladder.

Basic Information

Product Name	(R)-Darifenacin-D4 Hydrobromide
CAS No.	1261394-25-5
Molecular Formula	C28H30D4NO3•HBr
Molecular Weight	Approx. 508.5 g/mol
Synonyms	(3R)-1-[2-(2,3-Dihydro-5-benzofuranyl)ethyl]-α,α-diphenyl-3-pyrrolidineacetamide-d4 Hydrobromide; Darifenacin-d4 HBr; (R)-Darifenacin-d4 Hydrobromide; Deuterated Darifenacin Hydrobromide; Darifenacin (D4) Hydrobromide; UNII-7K8I7F8I8F (base); BRN 8280326 (base)
EINECS	Contact for details

Quality Control

Every batch of (R)-Darifenacin-D4 Hydrobromide is manufactured under strict quality management systems and undergoes comprehensive analytical testing. We provide full traceability and Certificates of Analysis (COA) that detail identity, purity (by HPLC), isotopic enrichment, and other critical parameters. Our quality commitment ensures compliance with the stringent requirements for pharmaceutical reference standards used in regulatory and research environments.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. This product is hygroscopic (moisture-sensitive); ensure the container is sealed after each use to prevent degradation from atmospheric moisture.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Isotopic Purity (D4)	≥ 98.0 atom % D
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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