Description

Vortioxetine Impurity 37 Hcl is a high-purity chemical reference standard specifically used in the pharmaceutical development and quality control of the active pharmaceutical ingredient (API) Vortioxetine HBr. This impurity is critical for ensuring the safety, efficacy, and regulatory compliance of the final drug product by enabling accurate identification, quantification, and control of process-related impurities. It is an essential material for analytical chemists and quality assurance professionals in pharmaceutical R&D and manufacturing, particularly for method validation, stability studies, and batch release testing.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of Vortioxetine Impurity 37 in API and finished drug products.
• Analytical Method Development & Validation: Critical for developing and validating sensitive HPLC, UPLC, or LC-MS methods to monitor impurity profiles.
• Quality Control & Batch Release: Used in routine QC testing to ensure Vortioxetine API batches meet stringent pharmacopeial (e.g., USP, EP) and ICH guidelines for impurity limits.
• Stability Studies: Employed to track the formation and level of this specific impurity under various stress conditions (heat, light, humidity) over the drug's shelf life.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to establish impurity specifications and justify safety thresholds.
• Process Chemistry Research: Aids in understanding and optimizing the Vortioxetine synthesis pathway to minimize the formation of this impurity.

Basic Information

Product Name	Vortioxetine Impurity 37 Hcl
CAS No.	2172212-69-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Vortioxetine Related Compound 37 Hydrochloride; Vortioxetine Process Impurity 37 HCl; 1-[2-(2,4-Dimethylphenylsulfanyl)phenyl]piperazine Hydrochloride (proposed); Vortioxetine HBr Impurity 37 HCl; Vortioxetine Specified Impurity 37; Vortioxetine EP Impurity HCL; Brintellix Impurity 37 Hydrochloride; Trintellix Impurity 37 HCl
EINECS	Contact for details

Quality Control

Every batch of Vortioxetine Impurity 37 Hcl is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced analytical techniques such as HPLC, LC-MS, and NMR to ensure compliance with pharmaceutical reference standard requirements. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, and is available upon request.

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 must be kept under inert conditions or in a desiccator after opening to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference
Purity (HPLC)	≥ 95.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

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