Description

Vortioxetine Impurity S CAS NO 1815608-51-5 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 ensuring the purity, safety, and efficacy of the final drug product by enabling the accurate identification and quantification of process-related impurities. It is an essential material for pharmaceutical R&D laboratories, quality assurance/quality control (QA/QC) departments, and regulatory affairs teams involved in the development and manufacturing of vortioxetine-based medications.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of Vortioxetine Impurity S in API and finished drug products.
• Method Development and Validation: Critical for developing and validating robust analytical methods, such as HPLC and UPLC, for impurity profiling.
• Quality Control & Batch Release: Used in routine QA/QC testing to ensure API batches meet stringent pharmacopeial (e.g., USP, EP) and internal purity specifications.
• Stability Studies: Employed to monitor the formation of this specific impurity during forced degradation and long-term stability studies of vortioxetine.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to demonstrate comprehensive impurity control and characterization.
• Process Chemistry Optimization: Helps chemists identify the source of the impurity during API synthesis, enabling process refinement to minimize its formation.

Basic Information

Product Name	Vortioxetine Impurity S
CAS No.	1815608-51-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Vortioxetine Related Compound S; Vortioxetine EP Impurity S; Vortioxetine USP Impurity S; 1-[2-(2,4-Dimethylphenylsulfanyl)phenyl]piperazine (Potential IUPAC fragment); Brintellix Impurity S; Trintellix Impurity S; Vortioxetine Process Impurity; Vortioxetine Specified Impurity
EINECS	Contact for details

Quality Control

Every batch of Vortioxetine Impurity S is manufactured and controlled under a strict quality management system. The material undergoes comprehensive analytical testing, including chromatographic purity assay and identity confirmation, to ensure it meets the high standards required for use as a reference standard. A detailed Certificate of Analysis (COA) is provided with each shipment, documenting batch-specific results. Our quality commitment supports compliance with cGMP and relevant pharmacopeial guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider desiccants or 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)	Individual unspecified impurity: ≤ 0.5% Total impurities: ≤ 2.0%
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.