Description

Solifenacin Impurity 7 (Solifenacin EP Impurity D) is a specified impurity associated with the active pharmaceutical ingredient Solifenacin succinate. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method validation and quality control. It is essential for manufacturers and analytical laboratories focused on ensuring the purity, safety, and regulatory compliance of Solifenacin-based drug products.

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 (HPLC/LC-MS): Critical for developing, validating, and verifying chromatographic methods to meet ICH Q2(R1) and pharmacopeial guidelines.
• Quality Control & Assurance (QC/QA): Used in routine batch testing to monitor impurity profiles and ensure drug substance and product specifications are met.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity data for drug master files (DMFs) and common technical documents (CTDs).
• Stability Studies: Employed to track the formation and levels of this specific degradation product under various stress conditions (ICH Q1A).
• Process Chemistry Research: Aids in understanding and optimizing the synthetic pathway of Solifenacin to minimize the formation of this impurity.

Basic Information

Product Name	Solifenacin Impurity 7 (Solifenacin EP Impurity D)
CAS No.	2216750-52-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Solifenacin Related Compound D; Solifenacin EP Impurity D; Solifenacin Impurity D; (1S,3'R)-1-Azabicyclo[2.2.2]oct-3-yl (1S)-1-phenyl-1,2,3,4-tetrahydroisoquinoline-2-carboxylate; UNII-9F8T3W7G4R; 9F8T3W7G4R; Solifenacin Process Impurity; Potential degradation product of Solifenacin.
EINECS	Contact for details

Quality Control

Our Solifenacin Impurity 7 is manufactured under strict quality management systems. Each batch is characterized and tested using advanced analytical techniques such as HPLC, LC-MS, and NMR to ensure high purity and accurate identification. Comprehensive Certificates of Analysis (COA) are provided, detailing purity, impurity profile, and results from all specified tests, supporting compliance with ICH, USP, and EP guidelines for reference standards.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (typically 15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept under dry conditions to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

Specification

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

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