Description

(R) Fesoterodine CAS NO 286930-02-7 is a high-purity, single-enantiomer active pharmaceutical ingredient (API) belonging to the antimuscarinic class. It is the pharmacologically active metabolite of fesoterodine fumarate, a key therapeutic agent used to manage overactive bladder (OAB) symptoms. This compound is of critical importance to pharmaceutical manufacturers and research institutions engaged in the development and production of advanced urological treatments. Its consistent quality and reliable supply are essential for ensuring the efficacy and safety of the final drug product.

Application

• Pharmaceutical API: Primary use as the active ingredient in the formulation of solid oral dosage forms for the treatment of overactive bladder.
• Reference Standard: Serves as a critical reference standard in analytical laboratories for quality control (QC) and research & development (R&D) of fesoterodine-based medications.
• Metabolite Studies: Used in pharmacokinetic and pharmacodynamic research to study the metabolism and activity profile of fesoterodine fumarate.
• Process Development: Employed in the development and optimization of synthetic routes for antimuscarinic drugs within pharmaceutical R&D.
• Impurity Profiling: Acts as a key marker in the identification and quantification of related substances and degradation products in drug substance and product analysis.
• Clinical Research Materials: Supplied for use in non-clinical and clinical trial material (CTM) manufacturing for new drug applications (NDAs).

Basic Information

Product Name	(R) Fesoterodine
CAS No.	286930-02-7
Molecular Formula	C26H37NO3
Molecular Weight	411.58 g/mol
Synonyms	(R)-Fesoterodine; (3R)-3-(Diisopropylamino)-1-phenyl-1-(2-thienyl)propan-1-ol; 5-Hydroxymethyl Tolterodine; (R)-5-Hydroxymethyl Tolterodine; Fesoterodine Related Compound A; Fesoterodine Impurity A; Toviaz Impurity A; (R)-5-HMT; 286930-02-7
EINECS	Contact for details

Quality Control

Our (R) Fesoterodine is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing to ensure it meets stringent specifications for identity, purity, and potency, aligning with ICH guidelines. A detailed Certificate of Analysis (COA) is provided with every shipment, documenting critical parameters such as chiral purity, assay, and related substances. We support compliance with cGMP, FDA, and other major pharmacopoeial standards (USP/EP) for pharmaceutical ingredients.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept under dry, inert conditions to maintain stability and prevent degradation. The original container should be kept sealed in a desiccated environment when not in use.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	≥98.0% (anhydrous basis)
Chiral Purity (HPLC)	≥99.0%
Related Substances (HPLC)	Total impurities ≤2.0% Any single impurity ≤0.5%
Residual Solvents (GC)	Complies with ICH Q3C
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.