Description

Vortioxetine Impurity 8 is a specified impurity of the active pharmaceutical ingredient (API) vortioxetine hydrobromide, used as a reference standard in analytical development and quality control. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure the purity, safety, and efficacy of the final drug product. It is primarily used by R&D scientists and QC professionals in the pharmaceutical industry for method validation, stability studies, and regulatory compliance testing.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in vortioxetine API and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing and validating HPLC, UPLC, or GC methods to monitor impurity profiles.
• Quality Control & Batch Release: Serves as a system suitability standard in routine QC testing to ensure analytical procedures remain fit for purpose.
• Stability Studies: Employed to track the formation of this specific impurity under various stress conditions (e.g., heat, humidity, light) as per ICH guidelines.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to establish impurity thresholds and justify specifications.
• Process Chemistry Research: Used to study and optimize the API synthesis pathway to minimize the formation of this impurity.

Basic Information

Product Name	Vortioxetine Impurity 8
CAS No.	2135576-73-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	1-[2-(2,4-Dimethylphenylsulfanyl)phenyl]piperazine; Vortioxetine Related Compound 8; Vortioxetine Process Impurity 8; Vortioxetine Specified Impurity 8
EINECS	Contact for details

Quality Control

Our Vortioxetine Impurity 8 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity analysis and spectroscopic confirmation (NMR, MS), to ensure identity, potency, and consistency. Certificates of Analysis (COA) with detailed chromatographic data are provided and traceable to primary reference standards, supporting compliance with ICH Q3A(R2) and Q3B(R2) guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at 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 desiccant conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 3.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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