Description

Vortioxetine Impurity 25 is a designated impurity standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) vortioxetine HBr. This compound is critical for ensuring the purity, safety, and efficacy of the final drug product by serving as a reference marker in chromatographic methods. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the development, production, and compliance testing 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.
• Analytical Method Development & Validation: Used to develop, optimize, and validate HPLC, UPLC, or LC-MS methods for impurity profiling.
• Quality Control & Batch Release Testing: Essential for routine QC testing to ensure API batches meet stringent pharmacopeial (e.g., USP, EP) or internal purity specifications.
• Stability Studies: Employed to monitor the formation of this specific impurity over time under various stress conditions (heat, light, humidity) to establish product shelf-life.
• Regulatory Submissions: Provides necessary impurity characterization data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDA).
• Research & Development: Used in R&D to understand the degradation pathways and synthesis by-products of vortioxetine.

Basic Information

Product Name	Vortioxetine Impurity 25
CAS No.	1639263-80-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Vortioxetine Related Compound 25; Vortioxetine Specified Impurity 25; 1-[2-(2,4-Dimethylphenylsulfanyl)phenyl]piperazine (Potential Core Structure); Vortioxetine Process Impurity; Lu AA21004 Impurity 25; Brintellix Impurity 25; Trintellix Impurity 25
EINECS	Contact for details

Quality Control

Our Vortioxetine Impurity 25 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including chromatographic purity assay and identity confirmation, 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, test methods, and traceability.

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. The material is typically hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (MS)	Mass spectrum conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0% w/w

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