Description

Vortioxetine Impurity 2 CAS NO 1293489-69-6 is a designated impurity standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) vortioxetine. This compound is critical for ensuring the purity, safety, and efficacy of the final drug product by serving as a reference marker in chromatographic methods. It is an essential material for pharmaceutical R&D laboratories, quality assurance/quality control (QA/QC) units, and regulatory affairs teams involved in the development and manufacturing of vortioxetine-based medications.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Vortioxetine Impurity 2 in API and finished drug products.
• Method Development and Validation: Critical for developing, optimizing, and validating analytical methods, particularly High-Performance Liquid Chromatography (HPLC) and Ultra-Performance Liquid Chromatography (UPLC).
• Quality Control and Batch Release: Used in routine QA/QC testing to monitor impurity levels, ensuring compliance with International Council for Harmonisation (ICH) Q3A and Q3B guidelines.
• Stability Studies: Employed to track the formation of this specific impurity over time under various stress conditions, supporting shelf-life determination.
• Regulatory Submissions: Provides essential data for Drug Master Files (DMFs), Investigational New Drug (IND) applications, and New Drug Applications (NDAs) to demonstrate control strategy.
• Process Chemistry Research: Aids in understanding and optimizing the vortioxetine synthesis pathway to minimize the formation of this impurity.

Basic Information

Product Name	Vortioxetine Impurity 2
CAS No.	1293489-69-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Vortioxetine Related Compound 2; Vortioxetine EP Impurity 2; Vortioxetine USP Impurity 2; 1-[2-(2,4-Dimethylphenylsulfanyl)phenyl]piperazine (Potential IUPAC-based name); Vortioxetine Process Impurity; Brintellix Impurity 2; Trintellix Impurity 2
EINECS	Contact for details

Quality Control

Our Vortioxetine Impurity 2 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing to ensure identity, purity, and consistency, aligning with current pharmacopeial standards (e.g., USP, EP). A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results from HPLC purity assay, related substances tests, and identification by spectroscopic methods (IR, MS).

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive); therefore, the container must be kept tightly sealed in a dry environment to prevent absorption of moisture. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unspecified impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0% w/w

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