Description

Vortioxetine Impurity 1 CAS NO 1293489-71-0 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient (API) vortioxetine hydrobromide. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling studies.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference standard for the identification and quantification of specific impurities in vortioxetine API and finished drug products.
• Analytical Method Development & Validation: Essential for developing and validating HPLC, UPLC, and other chromatographic methods to ensure accurate impurity detection.
• Quality Control & Assurance (QC/QA): Serves as a benchmark in routine quality control testing to monitor batch-to-batch consistency and purity of the API.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing necessary data on impurity identity and levels in accordance with ICH guidelines.
• Stability Studies: Employed in forced degradation and long-term stability studies of vortioxetine formulations to track impurity formation over time.
• Research & Development: Used in pharmaceutical R&D to study the degradation pathways and synthesis by-products of vortioxetine.

Basic Information

Product Name	Vortioxetine Impurity 1
CAS No.	1293489-71-0
Molecular Formula	C₁₈H₂₂N₂S
Molecular Weight	298.45 g/mol
Synonyms	1-[2-(2,4-Dimethylphenylsulfanyl)phenyl]piperazine; Vortioxetine Related Compound A; Vortioxetine Sulfoxide Impurity; Vortioxetine Process Impurity; Lu AA21004 Impurity 1; Brintellix Impurity 1; Trintellix Impurity 1
EINECS	Contact for details

Quality Control

Our Vortioxetine Impurity 1 is manufactured under strict quality systems to meet the exacting standards of pharmaceutical reference materials. Each batch is subjected to comprehensive analytical testing, including advanced chromatographic and spectroscopic techniques, to ensure high purity and accurate identification. A comprehensive Certificate of Analysis (COA) detailing purity, assay, and impurity profile is provided with every shipment to support your regulatory and quality requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry, cool place. This material is hygroscopic (moisture-sensitive) and should be handled under anhydrous conditions to maintain stability and purity.

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

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