Description

Tasimelteon Impurity 3 is a designated impurity of the non-melatonin receptor agonist Tasimelteon, used in the treatment of Non-24-Hour Sleep-Wake Disorder. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development, quality control, and regulatory compliance. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and R&D facilities involved in the synthesis, purification, and quality assurance of Tasimelteon API and its related drug products.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification, qualification, and quantification of impurities in Tasimelteon Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods to monitor impurity profiles.
• Quality Control & Batch Release Testing: Employed in routine QC laboratories to ensure API and drug product batches meet stringent purity specifications as per ICH guidelines.
• Regulatory Compliance & Filing: Supports the preparation of regulatory submission documents (e.g., for FDA, EMA) by providing characterized impurity data for drug master files (DMFs).
• Stability Studies: Used to track the formation and levels of this specific impurity during forced degradation and long-term stability studies of Tasimelteon formulations.
• Process Chemistry Research: Aids chemists in understanding and optimizing the Tasimelteon synthesis pathway to minimize the formation of this impurity.

Basic Information

Product Name	Tasimelteon Impurity 3
CAS No.	1803286-24-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Tasimelteon Related Compound 3; Tasimelteon Impurity B; Tasimelteon EP Impurity C; (1R,2R)-N-[(2-{2-[(2,3-Dihydro-1-benzofuran-4-yl)oxy]ethyl}cyclopropyl)methyl]propanamide; VEC-162 Impurity 3; Hetlioz Impurity 3
EINECS	Contact for details

Quality Control

Every batch of Tasimelteon Impurity 3 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced chromatographic techniques (HPLC, LC-MS) to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, related substances, and residual solvents, supporting your regulatory and quality requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at 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. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unknown impurity ≤ 1.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
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.