Description

Vortioxetine Imp.J CAS NO 2137588-68-0 is a designated impurity standard of the active pharmaceutical ingredient Vortioxetine, a modern antidepressant. This high-purity reference material is critical for ensuring the safety and efficacy of the final drug product by enabling accurate identification and quantification of this specific impurity during pharmaceutical development and quality control. It is an essential tool for analytical chemists and quality assurance professionals in the pharmaceutical industry, particularly those involved in the research, development, and manufacturing of central nervous system (CNS) therapeutics.

Application

• Pharmaceutical Impurity Profiling and Characterization: Used as a certified reference standard to identify and quantify Impurity J in Vortioxetine drug substance and finished dosage forms.
• Analytical Method Development and Validation: Serves as a critical component in developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for impurity analysis.
• 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 to ensure every batch of Vortioxetine API meets stringent regulatory limits for specified impurities.
• Regulatory Submissions: Provides definitive structural and purity data required for regulatory filings (e.g., with FDA, EMA) to demonstrate comprehensive impurity control.
• Pharmacopoeial Standards: Can be utilized as a working standard in laboratories to cross-verify against official pharmacopoeial monographs (e.g., USP, EP).

Basic Information

Product Name	Vortioxetine Impurity J
CAS No.	2137588-68-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Vortioxetine Related Compound J; Vortioxetine Imp J; Vortioxetine Specified Impurity J; 1-[2-(2,4-Dimethylphenylsulfanyl)phenyl]piperazine (Potential IUPAC fragment); Vortioxetine Process Impurity; Brintellix Impurity J; Trintellix Impurity J; Vortioxetine EP Impurity J
EINECS	Contact for details

Quality Control

Every batch of Vortioxetine Impurity J (CAS 2137588-68-0) is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing, including advanced chromatographic and spectroscopic techniques, to ensure identity, purity, and consistency meet the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, impurities, and identification.

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. Keep the container sealed to protect the material from moisture absorption.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 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.