Description

Vortioxetine Impurity 30 is a high-purity chemical reference standard used in the analytical development and quality control of the active pharmaceutical ingredient (API) vortioxetine. This compound is critical for pharmaceutical manufacturers and research laboratories to accurately identify, quantify, and monitor this specific impurity, ensuring the safety, efficacy, and regulatory compliance of the final drug product. It is an essential material for professionals engaged in pharmaceutical R&D, analytical method validation, and stability studies for antidepressant formulations.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of Vortioxetine Impurity 30 in API and finished drug products.
• Analytical Method Development & Validation: Used to develop, optimize, and validate HPLC, UPLC, and LC-MS methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to ensure vortioxetine API meets stringent pharmacopeial (e.g., USP, EP) impurity limits.
• Stability Studies: A key component in forced degradation and long-term stability studies to track impurity formation over time and under various stress conditions.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research & Development: Utilized in synthetic chemistry research to understand impurity formation pathways and to develop purification processes.

Basic Information

Product Name	Vortioxetine Impurity 30
CAS No.	1793058-29-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Vortioxetine Related Compound 30; Vortioxetine EP Impurity 30; Vortioxetine USP Impurity 30; 1-[2-(2,4-Dimethylphenyl)sulfanylphenyl]piperazine (Potential IUPAC-based name); Vortioxetine Process Impurity; Brintellix Impurity 30; Trintellix Impurity 30
EINECS	Contact for details

Quality Control

Every batch of Vortioxetine Impurity 30 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced chromatographic (HPLC, UPLC) and spectroscopic (NMR, MS) techniques to ensure compliance with pharmaceutical reference standard requirements. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, analytical methods, and traceability.

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 to maintain stability and purity. Keep the container tightly sealed when not in use.

Specification

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

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