Description

Solifenacin Related Compound 3 Succinate CAS NO 862207-70-3 is a high-purity reference standard and pharmaceutical intermediate. This compound is critical for quality control and analytical method development in the production of the active pharmaceutical ingredient (API) Solifenacin Succinate. It is primarily required by pharmaceutical manufacturers, contract research organizations (CROs), and analytical laboratories for research, development, and regulatory compliance activities.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification, purity assessment, and quantification of impurities in Solifenacin Succinate API and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing and validating chromatographic methods (HPLC, UPLC) to monitor process-related impurities.
• Quality Control & Assurance (QC/QA): Serves as a system suitability component and a known impurity marker in routine batch release testing to ensure product safety and efficacy.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing characterized impurity profiles required for drug master files (DMFs).
• Process Chemistry Research: Used in studies to understand and optimize the synthesis pathway of Solifenacin, helping to minimize the formation of this related compound.
• Stability Studies: Employed as a marker to track degradation products in forced degradation and long-term stability studies of Solifenacin formulations.

Basic Information

Product Name	Solifenacin Related Compound 3 Succinate
CAS No.	862207-70-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Solifenacin Impurity 3 Succinate; Solifenacin Succinate Related Compound 3; (1S)-(3R)-1-Azabicyclo[2.2.2]oct-3-yl (3RS)-1,2,3,4-tetrahydroisoquinoline-2-carboxylate succinate; Solifenacin EP Impurity C Succinate; Solifenacin USP Related Compound C Succinate; Degradation product of Solifenacin Succinate; Process impurity of Solifenacin
EINECS	Contact for details

Quality Control

Our Solifenacin Related Compound 3 Succinate is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods, to ensure it meets the stringent requirements for use as a reference standard. Certificates of Analysis (COA) with detailed chromatographic data are provided and can be tailored to support specific pharmacopeial (USP, EP) monograph requirements.

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 (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent absorption of moisture.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.10% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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