Description

Solifenacin Impurity 4 (Solifenacin EP Impurity H) is a high-purity reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Solifenacin Succinate. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure product safety, efficacy, and regulatory compliance by accurately identifying and quantifying related substances. It is essential for research and development, method validation, and routine batch testing within the pharmaceutical industry.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Solifenacin Succinate API and finished dosage forms.
• Analytical Method Development & Validation: Critical for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods to meet ICH Q2(R1) and Q3B(R2) guidelines.
• Quality Control & Batch Release: Used in routine QC laboratories to monitor impurity levels against established specifications, ensuring every batch meets pharmacopeial standards (USP, EP, JP).
• Stability Studies: Employed to track the formation of degradation products under various stress conditions (heat, light, humidity) as part of ICH stability-indicating methods.
• Regulatory Submissions: Provides essential data for Drug Master Files (DMFs), Common Technical Documents (CTDs), and other regulatory filings to agencies like the FDA and EMA.
• Research on Degradation Pathways: Supports investigative studies to understand the chemical degradation mechanisms of Solifenacin, aiding in formulation improvement.

Basic Information

Product Name	Solifenacin Impurity 4 (Solifenacin EP Impurity H)
CAS No.	732228-02-3
Molecular Formula	C23H26N2O2
Molecular Weight	362.47 g/mol
Synonyms	(1S,3'R)-1-Azabicyclo[2.2.2]octan-3'-yl (1S)-1-phenyl-3,4-dihydro-1H-isoquinoline-2-carboxylate; Solifenacin Related Compound H; Solifenacin Impurity H; VESIcare Impurity H; (3'R)-Solifenacin; YM-905 Impurity H
EINECS	Contact for details

Quality Control

Every batch of Solifenacin Impurity 4 is manufactured and analyzed under strict quality management systems. Comprehensive testing is performed using validated chromatographic (HPLC, GC) and spectroscopic (NMR, MS) methods to confirm identity, purity, and strength. A detailed Certificate of Analysis (COA) is provided with each shipment, containing batch-specific results and traceability data. Our quality systems are designed to support cGMP and ISO 9001 standards for pharmaceutical reference materials.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°F), in a dry environment. For long-term storage, consider storing at 2-8°C under inert atmosphere to ensure maximum stability.

Specification

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

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