Description

Vortioxetine Imp.Y CAS NO 1293489-64-1 is a high-purity chemical reference standard, specifically identified as a known impurity or degradation product of the active pharmaceutical ingredient Vortioxetine. This compound is critical for ensuring the quality, safety, and efficacy of pharmaceutical formulations through rigorous analytical control. It is primarily required by pharmaceutical manufacturers and analytical research laboratories involved in method development, stability studies, and regulatory compliance for antidepressant drug products.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference standard for the identification and quantification of specific impurities in Vortioxetine drug substance and finished dosage forms.
• Analytical Method Development and Validation (HPLC/LC-MS): Serves as a critical component for developing, optimizing, and validating chromatographic methods to ensure specificity and accuracy.
• Stability-Indicating Studies: Employed to monitor the formation of degradation products under various stress conditions (e.g., heat, light, humidity) as part of drug stability programs.
• Quality Control (QC) Testing: Essential for in-process and release testing in pharmaceutical manufacturing to confirm that impurity levels are within International Council for Harmonisation (ICH) guidelines.
• Regulatory Submissions: Supports regulatory filings (e.g., for FDA, EMA) by providing characterized impurity standards for specification justifications.
• Research and Development: Utilized in pharmaceutical R&D to understand the degradation pathways and chemical behavior of Vortioxetine.

Basic Information

Product Name	Vortioxetine Imp.Y
CAS No.	1293489-64-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Vortioxetine Related Compound Y; Vortioxetine Impurity Y; Vortioxetine Specified Impurity; 1-[2-(2,4-Dimethylphenylsulfanyl)phenyl]piperazine (Typical core structure); Vortioxetine Degradation Product; Lu AA21004 Impurity Y; Brintellix® Impurity; Trintellix® Impurity; Pharmaceutical Secondary Standard
EINECS	Contact for details

Quality Control

Every batch of Vortioxetine Imp.Y is manufactured and controlled under strict quality management systems. It undergoes comprehensive analytical testing, including HPLC purity assay and identity confirmation (IR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent absorption of moisture. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
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.