Description

Solifenacin Related Compound 2 Succinate is a high-purity reference standard and pharmaceutical intermediate. This compound is critical for quality control and analytical method development in the manufacturing of the active pharmaceutical ingredient (API) Solifenacin Succinate. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for ensuring product purity, safety, and compliance with stringent pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Solifenacin Succinate API batches.
• Analytical Method Development & Validation: Essential for developing and validating HPLC, UPLC, and other chromatographic methods in quality control laboratories.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., ANDA, NDA) by providing necessary impurity profiles and stability data to agencies like the FDA and EMA.
• Process Chemistry Research: Used in research to study degradation pathways and to optimize synthesis processes to minimize related substance formation.
• Quality Assurance/Quality Control (QA/QC): Serves as a system suitability component and for routine batch release testing in GMP environments.

Basic Information

Product Name	Solifenacin Related Compound 2 Succinate
CAS No.	1262506-09-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Solifenacin Impurity 2 Succinate; Solifenacin Succinate Related Compound 2; (1S)-(3R)-1-Azabicyclo[2.2.2]oct-3-yl (2S)-2,2-diphenyl-2-(1,2,3,4-tetrahydroisoquinolin-2-yl)acetate succinate; Solifenacin EP Impurity B Succinate; Solifenacin USP Related Compound 2 Succinate; Degradation product of Solifenacin Succinate
EINECS	Contact for details

Quality Control

Our Solifenacin Related Compound 2 Succinate is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including identification by spectroscopic methods (IR, NMR, MS), purity determination by HPLC, and control of residual solvents and heavy metals. A detailed Certificate of Analysis (COA) is provided with each shipment, confirming compliance with in-house specifications aligned with ICH guidelines and pharmacopeial standards (USP, EP).

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, which may affect stability and purity.

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 individual impurity ≤ 1.0%
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.