Description

Vortioxetine Impurity 3 is a designated impurity 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 serving as a reference marker in chromatographic methods. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and batch release testing.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of related substances in vortioxetine API and finished dosage forms.
• Analytical Method Development: Essential for developing and optimizing HPLC, UPLC, or GC methods to separate and detect process-related impurities.
• Quality Control & Assurance: Employed in routine batch analysis to monitor impurity levels and ensure compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., CMC sections for FDA, EMA) by providing impurity characterization data.
• Stability Studies: Used to track the formation of degradation products in vortioxetine formulations under various stress conditions.
• Research & Development: Facilitates impurity isolation, characterization, and toxicological studies during the drug development process.

Basic Information

Product Name	Vortioxetine Impurity 3
CAS No.	508233-82-7
Molecular Formula	C₁₈H₂₂N₂S
Molecular Weight	298.45 g/mol
Synonyms	1-[2-(2,4-Dimethylphenylsulfanyl)phenyl]piperazine; Vortioxetine Related Compound C; Vortioxetine Process Impurity; Vortioxetine Sulfur-containing Impurity; Brintellix Impurity 3; Trintellix Impurity 3; Lu AA21003 Impurity
EINECS	Contact for details

Quality Control

Every batch of Vortioxetine Impurity 3 is manufactured and analyzed under strict quality management systems. The product undergoes comprehensive testing, including identity confirmation by spectroscopic methods (IR, NMR, MS) and purity determination by validated chromatographic techniques (HPLC). A detailed Certificate of Analysis (COA) is provided with each shipment, documenting batch-specific results and confirming compliance with in-house specifications aligned with ICH guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing at 2-8°C. The material is hygroscopic (moisture-sensitive) and should be handled under anhydrous conditions to maintain stability.

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 unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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