Description

Ramelteon Impurity 3 CAS NO 880152-62-5 is a high-purity reference standard used for analytical and research purposes. This compound is a specified impurity of Ramelteon, a prescription medication used for the treatment of insomnia. It is critical for pharmaceutical manufacturers and analytical laboratories to ensure the quality, safety, and efficacy of the active pharmaceutical ingredient (API). This impurity standard is essential for method development, validation, and routine quality control testing in the pharmaceutical industry.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of Ramelteon Impurity 3 in drug substances and finished products.
• Analytical Method Development & Validation: Used to develop, optimize, and validate chromatographic methods, such as HPLC and UPLC, for impurity profiling.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to monitor and control impurity levels, ensuring compliance with ICH guidelines and regulatory specifications.
• Stability Studies: A key component in forced degradation and long-term stability studies to track impurity formation over time and under various stress conditions.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) submitted to agencies like the FDA and EMA.
• Research & Development: Used in synthetic chemistry research to study degradation pathways and to support the development of robust manufacturing processes for Ramelteon.

Basic Information

Product Name	Ramelteon Impurity 3
CAS No.	880152-62-5
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 C; Ramelteon EP Impurity C; TAK-375 Impurity 3; (S)-N-Ethyl-2-((8S)-1,2,3,8-tetrahydro-6,7-dihydroxy-2H-indeno[5,4-b]furan-8-yl)acetamide (isomer); Ramelteon Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Ramelteon Impurity 3 is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods, to ensure compliance with pharmaceutical reference standard requirements. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for identity, purity, and related substances. We support compliance with ICH Q3A/B, USP, and EP guidelines.

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 should be handled in a dry environment to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
Residue on Ignition	≤ 0.1%

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