Description

Vortioxetine Impurity 33 CAS NO 1474022-91-7 is a high-purity chemical reference standard used in the analytical profiling of the active pharmaceutical ingredient, vortioxetine. This impurity is critical for ensuring the safety, efficacy, and regulatory compliance of vortioxetine-based drug products by enabling accurate identification and quantification during quality control. It is an essential material for pharmaceutical R&D laboratories, quality assurance/control (QA/QC) units, and contract research organizations (CROs) focused on antidepressant development and manufacturing.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the calibration of analytical instruments (HPLC, LC-MS) in vortioxetine analysis.
• Method Development and Validation: Crucial for developing and validating stability-indicating analytical methods to monitor impurity profiles in drug substances and products.
• Quality Control & Assurance (QC/QA): Used in routine batch testing to ensure vortioxetine API and finished drug formulations meet stringent pharmacopeial (e.g., USP, EP) and ICH guidelines for impurity limits.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., CMC sections for FDA, EMA) by providing definitive characterization data for specified impurities.
• Stability Studies: Employed to identify and track degradation products formed under various stress conditions (heat, light, humidity) during drug product shelf-life studies.
• Process Chemistry Research: Aids in the optimization of vortioxetine synthesis by identifying and quantifying process-related impurities for purification strategy refinement.

Basic Information

Product Name	Vortioxetine Impurity 33
CAS No.	1474022-91-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Vortioxetine Related Compound 33; Vortioxetine EP Impurity 33; Vortioxetine USP Impurity 33; 1-[2-(2,4-Dimethylphenylsulfanyl)phenyl]piperazine (Potential IUPAC-based name); Vortioxetine Process Impurity; Brintellix Impurity 33; Trintellix Impurity 33; Vortioxetine Specified Impurity
EINECS	Contact for details

Quality Control

Every batch of Vortioxetine Impurity 33 is manufactured and controlled under a strict quality management system. The material undergoes comprehensive analytical testing, including chromatographic purity (HPLC), identity confirmation (IR, MS), and residual solvent analysis, to ensure it meets the high standards required for use as a pharmaceutical reference standard. A detailed Certificate of Analysis (COA) containing batch-specific data is provided with each shipment to support your regulatory and quality requirements.

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 nature, the container must be kept in a desiccated environment to prevent moisture absorption, which could compromise the stability and purity of the standard. 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)	Total impurities ≤ 5.0% Any single unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0% w/w

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