Description

(1R,3S-)Solifenacin Hydrochloride is a high-purity, single-enantiomer active pharmaceutical ingredient (API) used in the synthesis of advanced therapeutics. This compound is critical for ensuring the efficacy and safety of finished pharmaceutical products targeting specific muscarinic receptors. It is primarily required by pharmaceutical manufacturers and advanced research institutions for the development and production of urological medications.

Application

• Pharmaceutical API Synthesis: Primary raw material for the manufacture of solifenacin succinate, a medication for overactive bladder (OAB).
• Clinical Research & Development: Used in preclinical and clinical studies to investigate antimuscarinic agents.
• Reference Standard: Serves as a chromatographic and spectroscopic reference standard in quality control laboratories.
• Process Development: Employed in the optimization and scale-up of enantioselective synthesis routes.
• Formulation Development: Used in the development of novel drug delivery systems and dosage forms.
• Contract Manufacturing: Supplied to CDMOs (Contract Development and Manufacturing Organizations) for the production of generic or branded pharmaceuticals.

Basic Information

Product Name	(1R,3S-)Solifenacin Hydrochloride
CAS No.	180468-40-0
Molecular Formula	C23H26N2O2 • HCl
Molecular Weight	410.93 g/mol
Synonyms	(3R)-1-Azabicyclo[2.2.2]oct-8-yl (1S)-1-phenyl-1,2,3,4-tetrahydroisoquinoline-2-carboxylate hydrochloride; Solifenacin HCl; YM905 Hydrochloride; Vesicare® (brand name of the succinate salt); (1R,3S)-3-(1-Phenyl-1,2,3,4-tetrahydroisoquinolin-2-carbonyloxy)-1-azoniabicyclo[2.2.2]octane chloride
EINECS	Contact for details

Quality Control

Our (1R,3S-)Solifenacin Hydrochloride is manufactured under strict quality management systems. Each batch is tested to ensure compliance with stringent specifications for identity, purity, and enantiomeric excess, suitable for pharmaceutical applications. A comprehensive Certificate of Analysis (COA) detailing results for assay, related substances, residual solvents, and chiral purity is provided with every shipment.

Storage

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

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% - 102.0% (on anhydrous basis)
Enantiomeric Purity (Chiral HPLC)	≥ 99.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.10% Total impurities: ≤ 1.0%
Water (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.