Description

Solifenacin Impurity CAS NO 1956436-64-8 is a high-purity chemical reference standard used in the pharmaceutical development and quality control of Solifenacin Succinate, a medication for overactive bladder. This impurity is critical for ensuring the safety, efficacy, and regulatory compliance of the final drug product by enabling accurate identification and quantification of process-related substances. It is an essential material for analytical chemists and quality assurance professionals in pharmaceutical R&D and manufacturing.

Application

• Pharmaceutical Impurity Profiling and Characterization: Used as a certified reference material to identify and quantify this specific impurity during method development and validation.
• Analytical Method Development (HPLC/LC-MS): Serves as a critical standard for developing and optimizing chromatographic methods to separate and analyze Solifenacin and its related substances.
• Stability Studies and Forced Degradation Testing: Employed to monitor the formation of this impurity under various stress conditions (e.g., heat, light, humidity) to establish product shelf-life.
• Quality Control and Batch Release Testing: Essential for routine QC testing of active pharmaceutical ingredient (API) and finished drug products to ensure they meet stringent purity specifications (e.g., ICH Q3A/B).
• Regulatory Submissions and Compliance: Provides necessary data for regulatory filings (e.g., FDA, EMA) to demonstrate thorough understanding and control of the drug substance's impurity profile.
• Pharmacopoeial Standards (USP/EP): Can be utilized as a working standard in laboratories aligning with or contributing to monographs for Solifenacin Succinate.

Basic Information

Product Name	Solifenacin Impurity
CAS No.	1956436-64-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Solifenacin Related Compound; Solifenacin Process Impurity; Solifenacin Succinate Impurity; (1S,3'R)-1-Azabicyclo[2.2.2]oct-3-yl (1S)-1-phenyl-1,2,3,4-tetrahydroisoquinoline-2-carboxylate (related isomer); UNII-XXXX; Solifenacin EP Impurity; Solifenacin USP Impurity
EINECS	Contact for details

Quality Control

Every batch of Solifenacin Impurity (CAS 1956436-64-8) is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques such as HPLC, LC-MS, and NMR to ensure compliance with ICH Q3A (R2) and Q3B (R2) guidelines. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment to support your regulatory and quality requirements.

Storage

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

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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