Description

Ramelteon Impurity 10 is a designated process-related impurity of the active pharmaceutical ingredient Ramelteon, a melatonin receptor agonist used for the treatment of insomnia. This compound, with CAS No. 1149757-30-1, is critical for pharmaceutical research and development, serving as a key reference standard in analytical method development and quality control. It is primarily utilized by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure the purity, safety, and efficacy of Ramelteon-based drug products.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Ramelteon API and finished dosage forms.
• Analytical Method Development: Essential for developing and validating chromatographic methods (HPLC, UPLC) to monitor process-related impurities.
• Quality Control & Assurance (QC/QA): A critical component in the routine batch release testing of Ramelteon to comply with ICH Q3A/B guidelines.
• Stability Studies: Employed to track the formation of degradation products during forced degradation and long-term stability studies of Ramelteon.
• Regulatory Submissions: Provides necessary impurity data for Drug Master Files (DMFs), Investigational New Drug (IND), and New Drug Application (NDA) submissions to agencies like the FDA and EMA.
• Process Chemistry Research: Used to study and optimize the synthetic pathway of Ramelteon to minimize the formation of this specific impurity.

Basic Information

Product Name	Ramelteon Impurity 10
CAS No.	1149757-30-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Ramelteon Related Compound 10; Ramelteon EP Impurity 10; Ramelteon USP Impurity 10; (S)-N-[2-(1,6,7,8-Tetrahydro-2H-indeno[5,4-b]furan-8-yl)ethyl]propionamide Impurity; Ramelteon Process Impurity; TAK-375 Impurity 10
EINECS	Contact for details

Quality Control

Our Ramelteon Impurity 10 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity confirmation and identity verification via spectroscopic methods, to ensure it meets the stringent requirements for use as a pharmaceutical reference standard. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming compliance with relevant standards.

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)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 2.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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