Description

(R)-Ramelteon is the pharmacologically active enantiomer of the selective melatonin receptor agonist Ramelteon. This compound is of critical importance for research and development in the pharmaceutical industry, particularly for studying sleep-wake cycle regulation and developing novel therapeutic agents. It is primarily required by pharmaceutical R&D laboratories, academic research institutions, and manufacturers of active pharmaceutical ingredients (APIs) focusing on neurology and sleep medicine.

Application

• Pharmaceutical Reference Standard: Used as a high-purity standard for analytical method development, validation, and quality control in API and finished product manufacturing.
• Active Pharmaceutical Ingredient (API) Intermediate: Serves as a key chiral building block in the synthesis of the non-benzodiazepine hypnotic drug Ramelteon (TAK-375).
• Biochemical Research: Employed in in vitro and in vivo studies to investigate the specific pharmacological activity, metabolism, and binding affinity of the (R)-enantiomer at MT1 and MT2 melatonin receptors.
• Metabolite Studies: Utilized in the synthesis and identification of major metabolites (e.g., M-II) for pharmacokinetic and toxicological profiling.
• Chiral Separation Development: Acts as a critical compound for developing and optimizing chromatographic methods for enantiomeric purity analysis.
• Preclinical Development: Supports formulation studies, stability testing, and safety assessment in the drug development pipeline.

Basic Information

Product Name	(R)-Ramelteon
CAS No.	196597-27-0
Molecular Formula	C16H21NO2
Molecular Weight	259.34 g/mol
Synonyms	(R)-Ramelteon; (R)-N-[2-[(8S)-1,6,7,8-Tetrahydro-2H-indeno[5,4-b]furan-8-yl]ethyl]propionamide; (R)-TAK-375; (R)-Rozerem; Ramelteon (R-enantiomer); (8R)-8-[(1R)-2-(Propionylamino)ethyl]-6,7-dihydro-5H-indeno[5,4-b]furan; UNII-901K74Y5WI
EINECS	Contact for details

Quality Control

Our (R)-Ramelteon is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including chiral HPLC for enantiomeric excess, NMR and IR for structural confirmation, and rigorous purity analysis. We provide full traceability and Certificates of Analysis (COA) are available for all shipments, detailing assay, impurities, and residual solvents. Our quality commitment aligns with ICH guidelines for pharmaceutical intermediates.

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 must be kept under inert atmosphere (e.g., nitrogen or argon) after opening to prevent degradation. Keep the container tightly sealed in a desiccator for long-term storage.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Enantiomeric Excess (Chiral HPLC)	≥ 99.0%
Water Content (KF)	≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Heavy Metals	≤ 20 ppm

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