Description

Solifenacin Hydrochloride is a high-purity active pharmaceutical ingredient (API) primarily used as a potent and selective 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 institutions engaged in developing and producing urological therapeutics, ensuring reliable supply for global drug production.

Application

• Pharmaceutical API: Primary active ingredient in prescription medications for overactive bladder (OAB) and urinary incontinence.
• Finished Dosage Formulation: Used in the development and commercial production of oral solid dosage forms, primarily tablets.
• Research & Development: Serves as a key reference standard and building block in pharmacological research for muscarinic antagonists.
• Contract Manufacturing: Supplied to CDMOs (Contract Development and Manufacturing Organizations) for generic and branded drug production.
• Regulatory Submissions: Used to generate data for ANDA (Abbreviated New Drug Application) and NDA (New Drug Application) filings with global health authorities.

Basic Information

Product Name	Solifenacin Hydrochloride
CAS No.	180468-39-7
Molecular Formula	C23H26N2O2 • HCl
Molecular Weight	402.93 g/mol
Synonyms	Solifenacin HCl; YM-905; (3R)-1-Azabicyclo[2.2.2]oct-3-yl (1S)-1-phenyl-3,4-dihydro-1H-isoquinoline-2-carboxylate hydrochloride; Vesicare (brand name); VESIcare; Solifenacin succinate (related salt); Solifenacin fumarate (related salt)
EINECS	Contact for details

Quality Control

Our Solifenacin Hydrochloride is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing to ensure it meets high-purity standards suitable for pharmaceutical use, with typical purity levels exceeding 99.0%. Certificates of Analysis (COA) detailing results for identity, assay, related substances, residual solvents, and heavy metals are provided with every shipment. We support compliance with ICH Q7, GMP guidelines, and relevant pharmacopoeial standards.

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 product is hygroscopic (moisture-sensitive) and must be kept under dry, inert conditions to prevent degradation. The storage area should be well-ventilated and away from incompatible materials.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time corresponds to reference
Assay (HPLC)	98.5% - 101.0% (on anhydrous basis)
Related Substances (HPLC)	Total impurities ≤ 0.5% Any single impurity ≤ 0.2%
Water Content (KF)	≤ 0.5%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Residual Solvents (GC)	Complies with ICH Q3C

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