Description

Vortioxetine Impurity E is a specified impurity of the active pharmaceutical ingredient (API) Vortioxetine, a medication used in the treatment of major depressive disorder. This compound is critical for pharmaceutical manufacturers and analytical laboratories for quality control and regulatory compliance purposes. It is primarily required by R&D scientists, quality assurance professionals, and contract research organizations (CROs) involved in the development, validation, and batch release of Vortioxetine drug substances and products.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Vortioxetine Impurity E in drug substance and finished product testing.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC/UPLC methods to monitor impurity profiles.
• Quality Control & Batch Release: Serves as a system suitability standard and for preparing calibration curves in routine QC testing to ensure product safety and efficacy.
• Regulatory Submissions: Provides necessary data for impurity identification and qualification reports required by regulatory bodies like the FDA, EMA, and PMDA.
• Stability Studies: Used to track the formation and growth of this specific degradation product under various stress conditions (e.g., heat, light, humidity).
• Process Chemistry Research: Aids in understanding and optimizing the synthetic pathway of Vortioxetine to minimize the formation of this impurity.

Basic Information

Item	Detail
Product Name	Vortioxetine Impurity E
CAS No.	508233-77-0
Molecular Formula	C18H22N2S
Molecular Weight	298.45 g/mol
Synonyms	1-[2-(2,4-Dimethylphenylsulfanyl)phenyl]piperazine; Vortioxetine Related Compound E; Vortioxetine EP Impurity E; Vortioxetine USP Related Compound E; Lu AA21030 Impurity E; Brintellix Impurity E; Trintellix Impurity E
EINECS	Contact for details

Quality Control

Our Vortioxetine Impurity E is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC purity determination, residual solvent analysis (GC), and identity confirmation (IR, MS, NMR) to ensure it meets the stringent requirements for use as a pharmaceutical reference standard. A comprehensive Certificate of Analysis (CoA) is supplied with each shipment, detailing all test results and specifications.

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) and must be kept under inert conditions or in a desiccator after opening 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)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0% w/w

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