Description

Ramelteon Impurity 14 is a designated reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient Ramelteon. This compound is critical for ensuring the purity, safety, and efficacy of the final drug product by serving as a benchmark in chromatographic analysis. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the development, production, and quality assurance of sleep disorder medications.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of related substances in Ramelteon API and finished dosage forms.
• Analytical Method Development & Validation: Used to develop, optimize, and validate stability-indicating HPLC/UPLC methods for Ramelteon.
• Quality Control & Batch Release Testing: Essential for routine impurity profiling to ensure API and drug product batches meet stringent pharmacopeial (e.g., USP, EP) and ICH guidelines.
• Stability Studies: Employed to monitor the formation of degradation products under various stress conditions (e.g., heat, light, humidity) to establish shelf life.
• Regulatory Submissions: Provides necessary impurity characterization data for regulatory filings (e.g., FDA, EMA) to support drug approval.
• Research & Development: Used in synthetic chemistry research to understand degradation pathways and improve the manufacturing process of Ramelteon.

Basic Information

Product Name	Ramelteon Impurity 14
CAS No.	326793-94-6
Molecular Formula	C₁₆H₂₁NO₂
Molecular Weight	259.35 g/mol
Synonyms	(S)-N-[2-[(8S)-1,6,7,8-Tetrahydro-2H-indeno[5,4-b]furan-8-yl]ethyl]propionamide; Ramelteon Related Compound 14; Ramelteon EP Impurity D; TAK-375 Impurity 14; 8-[(1S)-2-(Propionylamino)ethyl]-1,6,7,8-tetrahydro-2H-indeno[5,4-b]furan; UNII-9J6A8U6R8K
EINECS	Contact for details

Quality Control

Every batch of Ramelteon Impurity 14 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity assay, and impurity profiling using advanced techniques like HPLC, GC, and NMR to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming compliance with relevant specifications.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. Keep the container in a dry, cool, and well-ventilated area. For long-term storage, consider storing under inert atmosphere to prevent potential degradation.

Specification

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

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