Description

Fesoterodine fumarate is a high-purity active pharmaceutical ingredient (API) used in the treatment of overactive bladder (OAB). This compound is the fumarate salt form of fesoterodine, a potent antimuscarinic agent that provides reliable therapeutic efficacy. It is a critical raw material for pharmaceutical manufacturers developing and producing extended-release tablet formulations. Global demand is driven by its established clinical profile and effectiveness in managing urinary frequency, urgency, and incontinence.

Application

• Pharmaceutical API: Primary active ingredient in prescription medications for overactive bladder syndrome.
• Extended-Release Formulations: Used in the development and commercial production of controlled-release oral tablets.
• Generic Drug Manufacturing: Serves as a key starting material for producers of generic antimuscarinic therapeutics.
• Clinical Research: Utilized in preclinical and clinical studies for new urological treatments.
• Drug Product Development: Employed in formulation R&D for optimizing drug delivery and stability profiles.

Basic Information

Product Name	Fesoterodine Fumarate
CAS No.	286930-03-8
Molecular Formula	C32H40N2O8
Molecular Weight	580.67 g/mol
Synonyms	Fesoterodine fumarate; Fesoterodine hydrogen fumarate; (R)-2-(3-Diisopropylamino-1-phenylpropyl)-4-(hydroxymethyl)phenyl isobutyrate fumarate; Toviaz (brand name API); 4-(Hydroxymethyl)phenyl 2-(3-diisopropylamino-1-phenylpropyl)isobutyrate fumarate; Fesoterodine (base) fumarate salt
EINECS	Contact for details

Quality Control

Our Fesoterodine fumarate 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, confirming compliance with agreed-upon standards. We support audits and can supply documentation relevant to cGMP, DMF, and other regulatory requirements for pharmaceutical ingredient supply.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry, and well-ventilated area at controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed to protect from moisture. Keep away from incompatible materials.

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)	Individual impurity: NMT 0.5% Total impurities: NMT 2.0%
Water Content (KF)	NMT 1.0%
Residue on Ignition	NMT 0.1%
Heavy Metals	NMT 20 ppm
Specific Rotation	Contact for details
Particle Size Distribution	Contact for details

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