Description

Vortioxetine Impurity 35 is a designated impurity of the active pharmaceutical ingredient (API) vortioxetine hydrobromide, a medication used in the treatment of major depressive disorder. This compound is critical for pharmaceutical research and development, serving as a key reference standard in analytical method development, stability studies, and quality control processes. It is essential for manufacturers and analytical laboratories focused on ensuring the purity, safety, and regulatory compliance of vortioxetine-based drug products.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of this specific impurity in vortioxetine API and finished dosage forms.
• Analytical Method Development & Validation: Critical for developing and validating sensitive HPLC, UPLC, or LC-MS/MS methods to monitor impurity profiles.
• Stability Studies & Forced Degradation: Employed to understand the degradation pathways of vortioxetine and to establish appropriate shelf-life specifications.
• Quality Control & Batch Release: Acts as a system suitability standard in routine QC testing to ensure drug substance and product meet ICH guidelines.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to demonstrate control over the impurity profile.
• Process Chemistry Research: Used to study and optimize synthetic routes to minimize the formation of this impurity during API manufacturing.

Basic Information

Product Name	Vortioxetine Impurity 35
CAS No.	640767-44-8
Molecular Formula	C₁₈H₂₂N₂S
Molecular Weight	298.45 g/mol
Synonyms	1-[2-(2,4-Dimethylphenyl)sulfanylphenyl]piperazine; Vortioxetine Related Compound 35; Vortioxetine Impurity F; Vortioxetine Sulfoxide Impurity; Lu AA21033 Impurity; Brintellix Impurity; Trintellix Impurity
EINECS	Contact for details

Quality Control

Our Vortioxetine Impurity 35 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including identification by spectroscopic methods (IR, NMR, MS), purity determination by HPLC, and control of related substances. A detailed Certificate of Analysis (COA) is provided with each shipment, confirming compliance with in-house specifications aligned with ICH Q3A/B guidelines. We support our clients' regulatory needs with full traceability and documentation.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%

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