Description

Vortioxetine Impurity 17 is a designated impurity of the active pharmaceutical ingredient (API) vortioxetine hydrobromide, a key compound used in the treatment of major depressive disorder. This impurity is critical for pharmaceutical manufacturers and analytical laboratories involved in the research, development, and quality control of vortioxetine-based drug products. It serves as a vital reference standard for ensuring drug purity, safety, and regulatory compliance. Professionals in pharmaceutical R&D, quality assurance (QA), and quality control (QC) rely on this high-purity standard for method development, validation, and batch release testing.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Vortioxetine Impurity 17 in drug substances and finished products.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods for vortioxetine API and formulations.
• Quality Control & Batch Release: Used in routine QC testing to monitor impurity profiles and ensure batches meet International Council for Harmonisation (ICH) guidelines and pharmacopeial specifications (USP/EP).
• Stability Studies: Employed to track the formation of this specific impurity under various stress conditions (heat, light, humidity) as part of forced degradation and shelf-life studies.
• Regulatory Submissions: Critical for preparing regulatory documentation (e.g., Drug Master Files, Common Technical Documents) to demonstrate comprehensive impurity control strategies for health authorities like the FDA and EMA.
• Research on Degradation Pathways: Utilized in academic and industrial research to study the chemical degradation pathways and metabolism of vortioxetine.

Basic Information

Product Name	Vortioxetine Impurity 17
CAS No.	2368241-98-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	1-[2-(2,4-Dimethylphenylsulfanyl)phenyl]piperazine; Vortioxetine Related Compound 17; Vortioxetine Process Impurity 17; Vortioxetine Specified Impurity 17; Brintellix Impurity 17; Trintellix Impurity 17; Lu AA21004 Impurity 17
EINECS	Contact for details

Quality Control

Every batch of Vortioxetine Impurity 17 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced chromatographic (HPLC, GC) and spectroscopic (NMR, MS) techniques to ensure compliance with industry standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results, including chromatographic purity, assay, and residual solvents, is provided and available upon request to support your regulatory and quality needs.

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. For long-term storage, consider storing under inert atmosphere to preserve stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 95.0%
Assay	≥ 97.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 3.0%
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.