Description

Vortioxetine Impurity CAS NO 853745-55-8 is a high-purity reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) vortioxetine. This compound is critical for ensuring the safety, efficacy, and regulatory compliance of the final drug product by accurately identifying and quantifying related substances. It is an essential material for pharmaceutical R&D laboratories, quality assurance/quality control (QA/QC) departments, and contract research organizations (CROs) involved in the development and manufacturing of vortioxetine-based medications.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of specific impurities in vortioxetine API and finished dosage forms.
• Method Development and Validation: Used in developing and validating analytical methods, such as HPLC, UPLC, and LC-MS, for impurity profiling.
• Quality Control & Stability Studies: Employed in routine batch release testing and forced degradation studies to monitor impurity levels and ensure product stability over time.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) that require detailed impurity characterization and control strategies.
• Research & Process Chemistry: Used by chemists to study the formation pathways of this impurity during the synthesis of vortioxetine, aiding in process optimization and impurity minimization.

Basic Information

Product Name	Vortioxetine Impurity
CAS No.	853745-55-8
Molecular Formula	C₁₈H₂₂N₂S
Molecular Weight	298.45 g/mol
Synonyms	Vortioxetine Related Compound; Vortioxetine Impurity Standard; 1-[2-(2,4-Dimethylphenylsulfanyl)phenyl]piperazine; Vortioxetine Process Impurity; Brintellix Impurity; Trintellix Impurity; Lu AA21004 Impurity; Vortioxetine Specified Unknown Impurity
EINECS	Contact for details

Quality Control

Every batch of Vortioxetine Impurity CAS NO 853745-55-8 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity assay, and impurity profiling using advanced chromatographic and spectroscopic techniques to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, related substances, and other critical quality attributes.

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 should be handled in a dry 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)	≥ 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.