Description

Vortioxetine Impurity 4 is a specified impurity of the antidepressant active pharmaceutical ingredient (API) Vortioxetine HBr. This compound is critical for analytical method development, stability studies, and ensuring the quality and safety of the final drug product. It is primarily used by pharmaceutical R&D laboratories, quality control (QC) departments, and manufacturers of reference standards to meet stringent regulatory requirements for impurity profiling and control.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the qualitative and quantitative analysis of Vortioxetine.
• Analytical Method Development and Validation: Essential for developing and validating HPLC, UPLC, or LC-MS methods to monitor and control this specific impurity.
• Stability Studies and Forced Degradation: Employed to identify and quantify degradation products formed under various stress conditions (e.g., heat, light, humidity).
• Quality Control and Batch Release: Serves as a system suitability and identification standard in the routine QC testing of Vortioxetine API and finished dosage forms.
• Regulatory Compliance and Filing: Supports the preparation of regulatory submission documents (e.g., for FDA, EMA) by providing necessary impurity data.
• Research and Process Chemistry: Used in synthetic route development and optimization to understand and minimize the formation of this impurity.

Basic Information

Item	Details
Product Name	Vortioxetine Impurity 4
CAS No.	1293489-77-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Vortioxetine Related Compound 4; Vortioxetine Impurity D; Vortioxetine EP Impurity D; Vortioxetine USP Impurity 4; 1-[2-(2,4-Dimethylphenylsulfanyl)phenyl]piperazine (Potential core structure); Vortioxetine Process Impurity; Brintellix Impurity 4; Trintellix Impurity 4
EINECS	Contact for details

Quality Control

Our Vortioxetine Impurity 4 is manufactured under strict quality control conditions suitable for pharmaceutical analysis. Each batch is characterized using advanced spectroscopic and chromatographic techniques to ensure high purity and correct identity. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing purity (by HPLC), identity confirmation (by NMR, MS), and other relevant analytical data to support your regulatory and research needs.

Storage

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

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 2.0% 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.