Description

Vortioxetine Impurity 52 is a high-purity chemical reference standard used in the pharmaceutical development and quality control processes. This compound is critical for the accurate identification, quantification, and monitoring of process-related impurities in the active pharmaceutical ingredient (API) vortioxetine. It is an essential tool for analytical chemists and quality assurance professionals in the pharmaceutical and contract research organization (CRO) sectors, ensuring drug safety and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for analytical method development and validation.
• Impurity Profiling: Used in HPLC, UPLC, and LC-MS analyses to identify and quantify this specific impurity in vortioxetine API batches.
• Quality Control & Assurance: A critical component in the release testing of vortioxetine to ensure it meets stringent pharmacopeial (e.g., USP, EP) specifications for impurity limits.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Stability Studies: Employed to track the formation of this impurity over time under various storage conditions.
• Process Chemistry R&D: Aids in the optimization of synthetic routes by identifying and minimizing the formation of this by-product.

Basic Information

Product Name	Vortioxetine Impurity 52
CAS No.	2476761-84-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Vortioxetine Related Compound 52; Vortioxetine EP Impurity 52; Vortioxetine USP Impurity 52; Vortioxetine Process Impurity 52; 1-[2-(2,4-Dimethylphenylsulfanyl)phenyl]piperazine (proposed); Brintellix Impurity 52; Trintellix Impurity 52; Lu AA21004 Impurity 52
EINECS	Contact for details

Quality Control

Our Vortioxetine Impurity 52 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC purity assay, identity confirmation (IR, MS), and residual solvent analysis, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing all test results and specifications is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. The product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain 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)	≥ 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% w/w

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