Description

Darifenacin-D4 is a deuterated analog of the active pharmaceutical ingredient Darifenacin, specifically labeled with four deuterium atoms. This stable isotope-labeled compound is essential for use as an internal standard in quantitative bioanalytical methods, ensuring the highest accuracy and reliability in pharmacokinetic and metabolism studies. It is a critical tool for researchers and quality control laboratories in the pharmaceutical industry, particularly those developing or manufacturing antimuscarinic drugs.

Application

• Internal Standard for LC-MS/MS: Primary application as a high-purity internal standard in Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) for the precise quantification of Darifenacin in biological matrices like plasma and urine.
• Drug Metabolism and Pharmacokinetics (DMPK): Used in ADME (Absorption, Distribution, Metabolism, and Excretion) studies to track the fate of the parent drug molecule in preclinical and clinical research.
• Bioanalytical Method Development and Validation: Critical for developing, validating, and ensuring the regulatory compliance of analytical methods according to FDA and ICH guidelines.
• Pharmaceutical Quality Control: Employed in impurity profiling and stability-indicating assays to monitor the quality and consistency of Darifenacin drug substance and finished products.
• Isotope Dilution Mass Spectrometry (IDMS): Serves as the labeled spike in IDMS, a definitive method for achieving maximum analytical accuracy and minimizing matrix effects.
• Clinical Research Support: Facilitates reliable data generation in clinical trials investigating Darifenacin's efficacy and safety profile.

Basic Information

Product Name	Darifenacin-D4
CAS No.	1095598-84-7
Molecular Formula	C28H27D4NO3
Molecular Weight	426.57 g/mol (approx.)
Synonyms	Darifenacin-d4; (3S)-1-[2-(2,3-Dihydro-5-benzofuranyl)ethyl]-α,α-diphenyl-3-pyrrolidineacetamide-d4; 3-(S)-[2-(2,3-Dihydro-5-benzofuranyl)ethyl]-2,2-diphenyl-N,N-diethyl-4-morpholinecarboxamide-d4; Enablex-d4; Emselex-d4; 1-[2-(2,3-Dihydro-5-benzofuranyl)ethyl]-α,α-diphenyl-3-(S)-pyrrolidineacetamide-d4; Deuterated Darifenacin
EINECS	Contact for details

Quality Control

Every batch of Darifenacin-D4 is manufactured and analyzed under strict quality systems. We provide comprehensive analytical data to support its use in regulated environments. The product is characterized by advanced techniques including NMR, HPLC, and Mass Spectrometry to confirm chemical structure, isotopic purity (≥98 atom % D), and chemical purity (typically ≥95%). A detailed Certificate of Analysis (COA) is supplied with each shipment, documenting batch-specific results.

Storage

Preserve in a tightly closed container, protected from light. Store at -20°C or below in a freezer. This product is hygroscopic (moisture-sensitive). Allow the sealed vial to equilibrate to room temperature before opening to minimize moisture uptake. For long-term storage, keep desiccated.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (NMR)	Conforms to structure
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 95%
Isotopic Purity	≥ 98 atom % D
Chemical Purity	≥ 95%
Residual Solvents (GC)	Meets ICH guidelines

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