Description

Solifenacin Related Compound 24 is a high-purity chemical reference standard used in pharmaceutical research and development. This compound is critical for ensuring the quality, safety, and efficacy of the active pharmaceutical ingredient, Solifenacin Succinate, through precise analytical control. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method validation, impurity profiling, and quality assurance processes.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in Solifenacin Succinate drug substance and finished products.
• Analytical Method Development and Validation: Serves as a critical standard for developing, calibrating, and validating chromatographic methods, such as HPLC and UPLC.
• Quality Control (QC) Testing: Employed in routine QC laboratories to monitor and control the purity of pharmaceutical batches against established specifications.
• Regulatory Compliance and Submissions: Essential for preparing documentation required by regulatory agencies (e.g., FDA, EMA) to demonstrate comprehensive impurity control.
• Stability Studies: Used to track the formation of degradation products in Solifenacin formulations under various stress conditions.
• Research and Development: Supports synthetic chemistry research for process optimization and impurity synthesis studies.

Basic Information

Product Name	Solifenacin Related Compound 24
CAS No.	1682642-69-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Solifenacin Impurity 24; Solifenacin EP Impurity I; Solifenacin Related Substance 24; (1S,3'R)-1-Azabicyclo[2.2.2]oct-8-yl 3-(diphenylmethoxy)-1-phenylpropanoate; UNII-9F8I4V8A4F; 9F8I4V8A4F; Solifenacin Related Compound I
EINECS	Contact for details

Quality Control

Every batch of Solifenacin Related Compound 24 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous testing to ensure compliance with high-purity reference standard requirements, including identity confirmation, purity assay, and impurity quantification. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results from advanced analytical techniques. We support compliance with ICH Q3A/B guidelines and other relevant pharmacopeial standards.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F). The product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.0%
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5%

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