Description

Solifenacin Related Compound 4 Succinate is a high-purity chemical reference standard, specifically a succinate salt form of a key related substance of the active pharmaceutical ingredient Solifenacin. This compound is critical for analytical method development, validation, and quality control processes in pharmaceutical manufacturing, ensuring the purity and safety of the final drug product. It is primarily required by pharmaceutical R&D laboratories, quality assurance departments, and contract research organizations (CROs) involved in the production and analysis of Solifenacin-based medications.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific process-related impurities in Solifenacin API and finished dosage forms.
• Analytical Method Development: Serves as a critical standard for developing and optimizing chromatographic methods, such as HPLC and UPLC, for impurity detection.
• Quality Control & Assurance: Essential for routine batch release testing to monitor and control impurity levels, ensuring compliance with ICH Q3A/B guidelines.
• Stability Studies: Employed to track the formation of degradation products under various stress conditions, supporting drug shelf-life determination.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Pharmacopoeial Testing: Used as a system suitability standard in testing procedures aligned with USP, EP, or other pharmacopoeial monographs.

Basic Information

Product Name	Solifenacin Related Compound 4 Succinate
CAS No.	862207-71-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Solifenacin Impurity 4 Succinate; Solifenacin Succinate Related Compound 4; (1S)-(3R)-1-Azabicyclo[2.2.2]oct-3-yl (2S)-2,2-diphenyl-2-(1,2,3,4-tetrahydroisoquinolin-2-yl)acetate succinate salt; Solifenacin EP Impurity C Succinate; Vesicare Related Compound 4 Succinate; YM905 Related Compound 4 Succinate
EINECS	Contact for details

Quality Control

Our Solifenacin Related Compound 4 Succinate is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment to support your regulatory and quality needs.

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 in a desiccated environment to maintain stability and purity. Handle with appropriate personal protective equipment in a well-ventilated area.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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