Description

Rac Fesoterodine-D14 Fumarate is a deuterium-labeled isotopologue of the active pharmaceutical ingredient fesoterodine fumarate, serving as a critical internal standard for precise quantitative analysis. This high-purity reference material is essential for ensuring accuracy and reliability in bioanalytical and pharmacokinetic studies, where distinguishing the drug from endogenous compounds is paramount. It is primarily utilized by pharmaceutical R&D laboratories, contract research organizations (CROs), and analytical service providers specializing in method development and validation for drug metabolism and excretion profiling.

Application

• Primary use as an internal standard in Liquid Chromatography-Mass Spectrometry (LC-MS/MS) for the quantification of fesoterodine and its metabolites in biological matrices.
• Method development and validation for bioequivalence and pharmacokinetic studies in clinical research.
• Calibration and quality control in high-throughput drug metabolism and pharmacokinetics (DMPK) screening.
• Supporting regulatory submissions to agencies like the FDA and EMA by providing traceable and stable isotope-labeled reference data.
• Use in impurity profiling and stability-indicating assays for fesoterodine fumarate drug substance and product.

Basic Information

Product Name	Rac Fesoterodine-D14 Fumarate
CAS No.	1185237-08-4
Molecular Formula	C32H34D14N2O6
Molecular Weight	~ 586.78 g/mol
Synonyms	Fesoterodine-d14 Fumarate; (R,S)-2-[(1R)-3-[Bis(1-methylethyl)amino]-1-phenylpropyl]-4-(hydroxymethyl)phenyl 2-methylpropanoate-d14 (2E)-2-Butenedioate (1:1); Fesoterodine (D14) Fumarate; Isotopically Labeled Fesoterodine Fumarate; Deuterated Fesoterodine Fumarate Internal Standard
EINECS	Contact for details

Quality Control

Every batch of our Rac Fesoterodine-D14 Fumarate is manufactured and analyzed under strict quality systems to ensure the highest isotopic and chemical purity for analytical applications. Our products undergo rigorous quality testing to ensure compliance with industry standards. Certificates of Analysis (COA) are available upon request, providing detailed results for identity, purity (HPLC), isotopic enrichment, and other critical parameters.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label/Certificate of Analysis. Due to its hygroscopic (moisture-sensitive) nature, the container should be kept in a dry environment and allowed to reach room temperature before opening to prevent condensation.

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)	≥ 98.0 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.