Description

Solifenacin Succinate is a high-purity active pharmaceutical ingredient (API) primarily used as a muscarinic receptor antagonist. This compound is critical for the formulation of medications designed to treat overactive bladder (OAB) syndrome, offering therapeutic efficacy by reducing involuntary detrusor muscle contractions. It is essential for pharmaceutical manufacturers and R&D laboratories engaged in developing and producing urological therapeutics and generic medicines.

Application

• Pharmaceutical API: Primary use as the active ingredient in prescription medications for overactive bladder (OAB).
• Finished Dosage Formulation: Direct compression into tablet formulations, including extended-release tablets.
• Generic Drug Manufacturing: Sourcing for the production of bioequivalent generic versions of branded antimuscarinic drugs.
• Clinical Research: Utilization in preclinical and clinical studies for new urological treatment modalities.
• Reference Standard: Serves as a high-purity chemical reference standard for quality control and analytical testing.
• Contract Manufacturing: Supply to CDMOs (Contract Development and Manufacturing Organizations) for client-specific drug production.

Basic Information

Product Name	Solifenacin Succinate
CAS No.	242478-38-2
Molecular Formula	C23H26N2O2 • C4H6O4
Molecular Weight	480.55 g/mol
Synonyms	Solifenacin Succinate; YM905; Vesicare (brand name); (3R)-1-Azabicyclo[2.2.2]oct-3-yl (1S)-1-phenyl-3,4-dihydro-1H-isoquinoline-2-carboxylate succinate; 1-Azabicyclo[2.2.2]octan-3-yl (1S)-1-phenyl-1,2,3,4-tetrahydroisoquinoline-2-carboxylate succinate
EINECS	Contact for details

Quality Control

Our Solifenacin Succinate is manufactured under strict quality systems, targeting compliance with ICH Q7 guidelines and relevant pharmacopoeial standards (e.g., USP, EP) for pharmaceutical ingredients. Each batch undergoes comprehensive analytical testing, including identity, purity, and impurity profile determination. A Certificate of Analysis (COA) documenting all test results is provided with every shipment to ensure full traceability and quality assurance for our B2B clients.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a low-humidity environment to prevent product degradation.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 1.5%
Heavy Metals	≤ 20 ppm

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