Description

Vortioxetine Impurity 32 is a designated pharmaceutical reference standard used in the analytical profiling and control of the active pharmaceutical ingredient (API) vortioxetine. This compound is critical for ensuring the purity, safety, and efficacy of vortioxetine-based drug products by serving as a key marker in chromatographic methods. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for research, method development, and stringent quality control processes.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of Vortioxetine Impurity 32 in vortioxetine API and finished drug products.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods to monitor impurities during API synthesis.
• Quality Control & Assurance (QC/QA): A critical component in routine batch release testing to ensure compliance with pharmacopeial (e.g., USP, EP) and ICH Q3A/B guidelines for impurity limits.
• Stability Studies: Employed to track the formation and level of this specific impurity in drug substances and products under various storage conditions over time.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to establish impurity profiles and justify specification limits.
• Process Chemistry Research: Used by R&D scientists to understand and optimize the vortioxetine synthesis pathway to minimize the formation of this impurity.

Basic Information

Product Name	Vortioxetine Impurity 32
CAS No.	1642185-28-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	1-[2-(2,4-Dimethylphenylsulfanyl)phenyl]piperazine; Vortioxetine Related Compound 32; Vortioxetine Process Impurity 32; Vortioxetine Sulfur-containing Impurity; Vortioxetine Synthetic Intermediate; Vortioxetine Degradant; Vortioxetine EP Impurity; Vortioxetine USP Impurity
EINECS	Contact for details

Quality Control

Every batch of Vortioxetine Impurity 32 is manufactured and handled under strict quality management systems. The product undergoes rigorous analytical testing, including chromatographic purity assays and spectroscopic identification, to ensure it meets the high standards required for use as a pharmaceutical reference material. A comprehensive Certificate of Analysis (COA) is supplied with each lot, detailing purity, assay results, and traceability data.

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 dry, inert conditions to maintain stability and purity. The container should be sealed tightly after each use to minimize exposure to atmospheric moisture.

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)	Total impurities ≤ 5.0% Any single unknown impurity ≤ 1.0%
Water Content (KF)	≤ 1.0%
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.