Description

Fesoterodine is a potent antimuscarinic agent, specifically a competitive muscarinic receptor antagonist. It is a prodrug that is rapidly and extensively converted by nonspecific esterases to its active metabolite, 5-hydroxymethyl tolterodine, which is responsible for its therapeutic effects. This compound is essential for the development and manufacturing of pharmaceutical formulations targeting overactive bladder (OAB) syndrome. It is a critical active pharmaceutical ingredient (API) for pharmaceutical companies, contract research organizations (CROs), and developers of generic and novel drug products.

Application

• Pharmaceutical API: Primary use as the active ingredient in prescription medications for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and frequency.
• Extended-Release Formulations: Used in the development and production of controlled-release tablet formulations to ensure sustained therapeutic delivery.
• Generic Drug Manufacturing: A key component for companies producing bioequivalent generic versions of branded antimuscarinic therapies.
• Clinical Research: Serves as a reference standard and raw material in pharmacokinetic, pharmacodynamic, and bioavailability studies.
• Drug Development: Utilized in preclinical and formulation research for new urological and anticholinergic therapeutics.
• Analytical Testing: Employed as a high-purity standard in quality control (QC) and quality assurance (QA) laboratories for HPLC, LC-MS, and other analytical methods.

Basic Information

Product Name	Fesoterodine
CAS No.	250214-44-9
Molecular Formula	C26H37NO4
Molecular Weight	427.58 g/mol
Synonyms	Fesoterodine Fumarate (common salt form); (R)-2-(3-(Diisopropylamino)-1-phenylpropyl)-4-(hydroxymethyl)phenyl isobutyrate; Toviaz (Brand Name); 4-Hydroxymethyl Tolterodine Prodrug; 5-Hydroxymethyl Tolterodine Precursor; Fesoterodine Base; Fesoterodine Free Base
EINECS	Contact for details

Quality Control

Our 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, consistent with ICH Q7 guidelines for Active Pharmaceutical Ingredients (APIs). We provide full traceability and support regulatory submissions. A detailed Certificate of Analysis (COA) is supplied with every shipment, confirming compliance with agreed specifications.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry, and well-ventilated place at 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.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time matches reference
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Related Substances (HPLC)	Total impurities ≤ 1.0% Any single impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm

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