Description

Tasimelteon Impurity 4 is a designated impurity reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient Tasimelteon. This compound is critical for ensuring the purity, safety, and efficacy of pharmaceutical formulations by serving as a benchmark in chromatographic analysis. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the development and quality assurance of Tasimelteon-based therapies.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of related substances in Tasimelteon API and finished dosage forms.
• Analytical Method Development & Validation: Used as a critical component in developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to monitor and control impurity levels, ensuring compliance with ICH Q3A/B guidelines.
• Regulatory Submissions: Essential for preparing documentation for regulatory filings (e.g., with FDA, EMA) to demonstrate comprehensive impurity characterization and control strategies.
• Stability Studies: Used to track the formation and growth of this specific impurity during forced degradation and long-term stability studies of Tasimelteon products.
• Research & Development: Facilitates process chemistry research aimed at understanding and minimizing the formation of this impurity during API synthesis.

Basic Information

Product Name	Tasimelteon Impurity 4
CAS No.	1803286-27-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	1-[(1R,2R)-2-(2,3-Dihydro-1-benzofuran-4-yl)cyclopropyl]-2,2,2-trifluoroethan-1-ol; Tasimelteon Related Compound 4; Tasimelteon EP Impurity D; Tasimelteon USP Impurity 4; (1R,2R)-2-(2,3-Dihydrobenzofuran-4-yl)-1-(2,2,2-trifluoro-1-hydroxyethyl)cyclopropane
EINECS	Contact for details

Quality Control

Our Tasimelteon Impurity 4 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure it meets the high standards required for pharmaceutical reference materials. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profile, supporting compliance with ICH guidelines and regulatory requirements.

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 in a desiccated environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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