Description

Vortioxetine Impurity 34 is a designated reference standard used for the analytical profiling and quality control of the active pharmaceutical ingredient (API) vortioxetine hydrobromide. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure product purity, safety, and regulatory compliance by accurately identifying and quantifying this specific impurity. It is essential for research and development, method validation, and stability studies within the pharmaceutical industry.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of Vortioxetine Impurity 34 in vortioxetine API and finished drug products.
• Analytical Method Development & Validation: Crucial for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods to monitor impurities.
• Quality Control & Assurance (QC/QA): Used in routine batch release testing to ensure API and drug product specifications meet pharmacopeial (e.g., USP, EP) and ICH guidelines.
• Stability Studies: Employed to track the formation of this impurity over time under various stress conditions (e.g., heat, humidity, light) to establish shelf life.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., CMC sections for FDA, EMA) by providing definitive impurity characterization data.
• Process Chemistry Research: Aids in understanding and optimizing the vortioxetine synthesis pathway to minimize the formation of this specific impurity.

Basic Information

Item	Detail
Product Name	Vortioxetine Impurity 34
CAS No.	640767-43-7
Molecular Formula	C18H22N2O2S
Molecular Weight	330.45 g/mol
Synonyms	1-[2-(2,4-Dimethylphenylsulfanyl)phenyl]piperazine; Vortioxetine Related Compound 34; Vortioxetine EP Impurity G; Vortioxetine USP Impurity; Brintellix Impurity; Trintellix Impurity; Vortioxetine Sulfur-containing Impurity; Vortioxetine Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Vortioxetine Impurity 34 is manufactured and analyzed under strict quality management systems. The material undergoes comprehensive testing, including identification by spectroscopic methods (IR, NMR, MS), purity determination by HPLC, and control of related substances and residual solvents. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing all test results against predefined specifications. Our quality standards align with ICH Q3A/B guidelines for impurities in new drug substances and products.

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 should be kept in a desiccated environment to prevent degradation. 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)	Any individual impurity ≤ 1.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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