Description

Ramelteon Impurity 6 is a designated impurity standard of the active pharmaceutical ingredient Ramelteon, a melatonin receptor agonist used for the treatment of insomnia. This high-purity reference material is critical for analytical method development, validation, and quality control processes in pharmaceutical manufacturing. It is essential for researchers and quality assurance professionals in the pharmaceutical and biotechnology industries who require reliable standards to ensure product safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the analysis of Ramelteon API and finished dosage forms.
• Analytical Method Development: Used to develop and optimize chromatographic methods (HPLC, UPLC) for impurity profiling.
• Quality Control & Assurance: Critical for routine batch testing to monitor and control impurity levels in accordance with ICH guidelines.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity characterization data.
• Stability Studies: Employed to identify and quantify degradation products in forced degradation and long-term stability studies of Ramelteon.
• Research & Development: Serves as a key reagent in synthetic chemistry research and impurity synthesis pathway studies.

Basic Information

Product Name	Ramelteon Impurity 6
CAS No.	221530-38-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Ramelteon Related Compound 6; Ramelteon EP Impurity B; Ramelteon USP Impurity; (S)-N-[2-(1,6,7,8-Tetrahydro-2H-indeno[5,4-b]furan-8-yl)ethyl]propionamide Impurity; TAK-375 Impurity 6; 8-[(2S)-2-Aminopropyl]-1,6,7,8-tetrahydro-2H-indeno[5,4-b]furan Impurity
EINECS	Contact for details

Quality Control

Our Ramelteon Impurity 6 is manufactured under strict quality systems to ensure high purity and batch-to-batch consistency suitable for pharmaceutical analysis. Each batch undergoes rigorous testing, including identification by spectroscopic methods and purity determination by chromatographic techniques. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing the results against established specifications. Our quality commitment aligns with cGMP principles to support your regulatory needs.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

Specification

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

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