Description

4-Hydroxy Solifenacin n-Oxide is a key pharmaceutical intermediate and metabolite of the active pharmaceutical ingredient Solifenacin. This compound matters for its critical role in the development, analysis, and quality control of urological medications targeting overactive bladder syndrome. Pharmaceutical R&D laboratories and API manufacturers need this high-purity intermediate for synthesis optimization, metabolic studies, and as a certified reference standard.

Application

• Pharmaceutical Intermediate: Used in the synthesis and process development of Solifenacin succinate and related analogs.
• Metabolite Reference Standard: Serves as a certified standard for pharmacokinetic and drug metabolism studies in clinical and preclinical research.
• Analytical Chemistry: Employed as a high-purity impurity standard for HPLC, LC-MS, and other chromatographic methods in quality control laboratories.
• Drug Discovery & Development: Utilized in medicinal chemistry programs for structure-activity relationship (SAR) studies of muscarinic receptor antagonists.
• Regulatory Compliance: Essential for preparing impurity profiles and regulatory submission documents (e.g., for FDA, EMA) requiring characterization of drug-related substances.

Basic Information

Product Name	4-Hydroxy Solifenacin n-Oxide
CAS No.	2747991-39-3
Molecular Formula	C23H26N2O4
Molecular Weight	394.47 g/mol
Synonyms	Solifenacin N-Oxide Hydroxy Metabolite; (1S)-(3R)-1-Azabicyclo[2.2.2]oct-3-yl (1S)-1-phenyl-1,2,3,4-tetrahydroisoquinoline-2-carboxylate N-Oxide, 4-Hydroxy derivative; 4-Hydroxy Solifenacin N-Oxide; 4-OH-Solifenacin N-Oxide; YM905 N-Oxide Metabolite; Vesicare® Metabolite Standard
EINECS	Contact for details

Quality Control

Our 4-Hydroxy Solifenacin n-Oxide is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, LC-MS for identity confirmation, and residual solvent analysis, to ensure it meets the stringent requirements for pharmaceutical reference standards and advanced intermediates. Certificates of Analysis (COA) with detailed chromatographic data are provided for every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing under inert atmosphere at -20°C to maximize stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Water Content (KF)	≤ 0.5%
Residual Solvents (GC)	Meets ICH Q3C guidelines
Heavy Metals	< 10 ppm

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