Description

Solifenacin Impurity 19 is a designated impurity standard used in the pharmaceutical development and quality control of the active pharmaceutical ingredient (API) Solifenacin succinate. This compound is critical for ensuring the purity, safety, and efficacy of the final drug product by serving as a reference marker in analytical testing. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method validation, stability studies, and batch release testing.

Application

• Pharmaceutical Reference Standard: Used 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: Essential for developing and validating sensitive HPLC, UPLC, or LC-MS methods to monitor impurity profiles.
• Quality Control & Batch Release: A critical component in the routine QC testing of API batches to ensure compliance with ICH Q3A(R2) and Q3B(R2) guidelines on impurities.
• Stability Studies: Employed to track the formation of degradation products under various stress conditions (e.g., heat, light, humidity) as per ICH stability guidelines.
• Regulatory Submissions: Provides necessary data on impurity characterization and control strategies for regulatory filings (e.g., FDA, EMA).
• Research & Development: Supports process chemistry research to understand and minimize impurity formation during API synthesis.

Basic Information

Product Name	Solifenacin Impurity 19
CAS No.	1422505-78-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Solifenacin Related Compound 19; Solifenacin EP Impurity 19; Solifenacin USP Impurity 19; (1S,3'R)-1-Azabicyclo[2.2.2]oct-3-yl (3RS)-1-phenyl-1,2,3,4-tetrahydroisoquinoline-3-carboxylate; Solifenacin Isomer Impurity; Vesicare Impurity 19
EINECS	Contact for details

Quality Control

Our Solifenacin Impurity 19 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC purity, identity confirmation (IR, MS), and residual solvent analysis, to ensure it meets the stringent requirements for pharmaceutical impurity standards. Certificates of Analysis (COA) with detailed chromatographic data and traceable lot numbers are provided to support your regulatory and quality needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. This material is hygroscopic (moisture-sensitive) and must be handled under anhydrous conditions to maintain stability and purity.

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 guidelines
Water Content (KF)	≤ 5.0%

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