Description

Wortoxetine Impurity T: Acetyl Wortoxetine is a designated impurity standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Wortoxetine. This compound is critical for ensuring the purity, safety, and efficacy of pharmaceutical formulations by serving as a reference marker in chromatographic analysis. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in research, development, and quality assurance processes.

Application

• Primary use as a certified reference standard (CRS) for the identification and quantification of Acetyl Wortoxetine in Wortoxetine API.
• Critical component in method development and validation for HPLC, UPLC, and LC-MS analytical procedures.
• Essential for impurity profiling and characterization studies to meet ICH Q3A(R2) and Q3B(R2) regulatory guidelines.
• Used in stability studies to monitor degradation pathways and establish shelf-life specifications.
• Serves as a system suitability test component in quality control (QC) laboratories for batch release testing.
• Valuable for pharmacological and toxicological research to understand the impact of specific impurities.

Basic Information

Product Name	Wortoxetine Impurity T: Acetyl Wortoxetine
CAS No.	1801352-86-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Acetyl Wortoxetine; Wortoxetine Acetyl Impurity; Wortoxetine Related Compound T; Wortoxetine Impurity T; 1-[2-(2,4-Dimethylphenyl)sulfanylphenyl]ethanone (probable core structure); Wortoxetine Process Impurity; Wortoxetine Degradant; Wortoxetine EP Impurity T
EINECS	Contact for details

Quality Control

Every batch of Wortoxetine Impurity T is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and strength testing using validated chromatographic (HPLC/UPLC) and spectroscopic (MS, NMR) methods to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment to support your regulatory submissions and internal QC protocols.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. Keep the container in a dry, cool, and well-ventilated place. Handle and store in accordance with current Good Manufacturing Practice (cGMP) principles.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0% w/w

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