Description

Vortioxetine Impurity 15 is a designated process-related impurity and reference standard used in the analytical profiling of the active pharmaceutical ingredient (API), Vortioxetine HBr. This compound is critical for ensuring the quality, safety, and efficacy of the final drug product by enabling precise identification and quantification during manufacturing. It is primarily required by pharmaceutical R&D laboratories, quality control (QC) departments, and contract research organizations (CROs) involved in the development and production of Vortioxetine-based medications.

Application

• Pharmaceutical Reference Standard: Serves as a certified external standard for the calibration of analytical instruments (HPLC, LC-MS) to accurately quantify impurity levels in Vortioxetine API batches.
• Method Development and Validation: Essential for developing, optimizing, and validating stability-indicating analytical methods as per ICH Q2(R1) guidelines.
• Quality Control and Release Testing: Used in routine QC testing to monitor and control the level of this specific impurity, ensuring compliance with strict pharmacopeial specifications (e.g., ICH Q3A/B).
• Stability Studies: Employed in forced degradation and long-term stability studies to track the formation of Vortioxetine Impurity 15 under various stress conditions.
• Regulatory Submissions: Provides necessary impurity characterization data for regulatory filings (e.g., ANDA, NDA) with agencies like the US FDA and EMA.
• Process Chemistry Research: Aids chemists in understanding and optimizing the synthetic pathway of Vortioxetine to minimize the formation of this impurity.

Basic Information

Product Name	Vortioxetine Impurity 15
CAS No.	2099147-02-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Vortioxetine Related Compound 15; Vortioxetine EP Impurity G; Vortioxetine USP Impurity; 1-[2-(2,4-Dimethylphenylsulfanyl)phenyl]piperazine (Potential IUPAC); Vortioxetine Process Impurity; Brintellix Impurity; Trintellix Impurity; Lu AA21004 Impurity
EINECS	Contact for details

Quality Control

Every batch of Vortioxetine Impurity 15 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using validated methods (HPLC, NMR, MS) to ensure they meet the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is supplied with each shipment, detailing batch-specific results, and our quality systems support compliance with cGMP and ISO 9001 standards.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. Keep the container in a dry, cool, and well-ventilated area. Handle and store in accordance with good laboratory practices.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 95.0%
Assay	≥ 98.0% (on dried basis)
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Heavy Metals	≤ 20 ppm

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