Description

Vortioxetine Impurity 29 is a designated process-related impurity or degradation product of the antidepressant active pharmaceutical ingredient (API) Vortioxetine HBr. This compound is critical for pharmaceutical research and development, serving as a reference standard for analytical method development, validation, and quality control. It is essential for manufacturers and analytical laboratories focused on ensuring the purity, safety, and regulatory compliance of Vortioxetine-based drug products. The CAS number for this compound is 1928741-88-1.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Vortioxetine API and finished dosage forms.
• Analytical Method Development: Critical for developing and optimizing chromatographic methods (HPLC, UPLC) to separate and detect process-related impurities.
• Quality Control & Assurance: Used in routine batch testing to monitor impurity profiles and ensure API purity meets pharmacopeial (USP, EP) and ICH Q3A/B guidelines.
• Stability Studies: Employed to track the formation of degradation products under various stress conditions (light, heat, humidity) to establish shelf-life.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Process Chemistry Research: Aids in understanding and optimizing the Vortioxetine synthesis pathway to minimize the formation of this specific impurity.

Basic Information

Product Name	Vortioxetine Impurity 29
CAS No.	1928741-88-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Vortioxetine Related Compound 29; Vortioxetine EP Impurity 29; Vortioxetine USP Impurity 29; 1-[2-(2,4-Dimethylphenylsulfanyl)phenyl]piperazine (proposed core structure); Vortioxetine Process Impurity; Brintellix Impurity; Trintellix Impurity
EINECS	Contact for details

Quality Control

Every batch of Vortioxetine Impurity 29 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing, including advanced chromatographic and spectroscopic techniques, to ensure identity, purity, and stability compliance with industry standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results, including HPLC purity, is provided with each shipment to support your regulatory and research needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F), in a dry environment. For long-term storage, consider storing desiccated at 2-8°C. Handle and store in accordance with good laboratory practices.

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)	Single unspecified impurity ≤ 2.0% Total impurities ≤ 5.0%
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.