Description

Vortioxetine Impurity 2 CAS NO 508233-75-8 is a designated reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) vortioxetine. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure product purity, safety, and regulatory compliance. It is primarily required for method development, validation, and routine batch testing within the pharmaceutical and life sciences sectors.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of related substances in vortioxetine API and finished drug products.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods to monitor impurity profiles.
• Quality Control & Batch Release Testing: Used in routine QC laboratories to confirm that vortioxetine batches meet stringent pharmacopeial (e.g., USP, EP) or internal purity specifications.
• Stability Studies: Employed to track the formation and growth of this specific impurity during forced degradation and long-term stability studies of vortioxetine formulations.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to characterize the impurity profile of the drug substance.
• Research & Development: Used in R&D settings to study the synthesis pathway, degradation routes, and metabolic pathways of vortioxetine.

Basic Information

Product Name	Vortioxetine Impurity 2
CAS No.	508233-75-8
Molecular Formula	C18H22N2S
Molecular Weight	298.45 g/mol
Synonyms	1-[2-(2,4-Dimethylphenylsulfanyl)phenyl]piperazine; Vortioxetine Related Compound B; Vortioxetine EP Impurity B; Vortioxetine USP Impurity; Brintellix Impurity; Trintellix Impurity; Vortioxetine Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Vortioxetine Impurity 2 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced chromatographic (HPLC, GC) and spectroscopic (NMR, MS) techniques to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, and is available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. Keep the container in a dry, cool, and well-ventilated place. For long-term storage, consider storing under inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 3.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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