Description

Ramelteon Impurity 9 is a designated impurity standard used in the pharmaceutical development and quality control of the sleep medication Ramelteon. This high-purity reference material is critical for ensuring the safety, efficacy, and regulatory compliance of the active pharmaceutical ingredient (API). It is primarily required by analytical laboratories, pharmaceutical manufacturers, and research institutions involved in method validation, stability studies, and impurity profiling to meet stringent pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the quantitative and qualitative analysis of Ramelteon API and finished dosage forms.
• Analytical Method Development & Validation (HPLC/LC-MS): Used as a critical component in developing and validating chromatographic methods for impurity separation and detection.
• Quality Control & Assurance (QC/QA): Essential for routine batch testing to monitor and control the levels of this specific impurity, ensuring product consistency.
• Stability Studies: Employed to identify and quantify degradation products that may form under various stress conditions (e.g., heat, light, humidity).
• Regulatory Compliance & Filings: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary data on impurity identification and qualification.
• Research & Development: Used in synthetic chemistry research to study the formation pathways and chemical behavior of this impurity.

Basic Information

Product Name	Ramelteon Impurity 9
CAS No.	1356395-13-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Ramelteon Related Compound 9; Ramelteon Specified Impurity 9; (S)-N-[2-[(8S)-2,6,7,8-Tetrahydro-1H-cyclopenta[e]indol-8-yl]ethyl]propionamide Impurity; Ramelteon EP Impurity I; Ramelteon Process Impurity; TAK-375 Impurity 9
EINECS	Contact for details

Quality Control

Every batch of Ramelteon Impurity 9 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and chromatographic testing to ensure compliance with pharmacopeial standards for reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results, including HPLC purity, is provided with each shipment to support your regulatory and quality requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing desiccated at 2-8°C.

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)	Individual unspecified impurity: ≤ 1.0% 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.