Description

Ramelteon CAS NO 196597-26-9 is a selective melatonin receptor agonist (MT1 and MT2) specifically developed for the treatment of insomnia characterized by difficulty with sleep onset. This high-purity active pharmaceutical ingredient (API) is critical for ensuring the efficacy and safety of finished dosage forms. It is primarily required by pharmaceutical manufacturers and research institutions engaged in the development and production of sleep disorder therapeutics and related neurological research.

Application

• Pharmaceutical API: Primary use as the active ingredient in prescription sleep aid medications for treating insomnia.
• Finished Dosage Form Manufacturing: Direct compression into tablets or encapsulation for commercial pharmaceutical products.
• Clinical Research: Utilization in clinical trials studying sleep disorders, circadian rhythm dysfunctions, and melatonin receptor pharmacology.
• Preclinical & Biomedical Research: Investigation of sleep mechanisms, neuropharmacology, and receptor-specific drug effects in laboratory studies.
• Reference Standard: Serves as a high-purity chemical standard for analytical method development, validation, and quality control testing in QC/QA laboratories.
• Formulation Development: Used in R&D for developing new drug delivery systems, generics, or combination therapies targeting sleep regulation.

Basic Information

Product Name	Ramelteon
CAS No.	196597-26-9
Molecular Formula	C16H21NO2
Molecular Weight	259.34 g/mol
Synonyms	TAK-375; Rozerem (Trade Name); (S)-N-[2-(1,6,7,8-Tetrahydro-2H-indeno[5,4-b]furan-8-yl)ethyl]propionamide; Ramelteonum; UNII-901AS54MBC; 8-[(1S)-2-(Propionylamino)ethyl]-1,6,7,8-tetrahydro-2H-indeno[5,4-b]furan-2-one
EINECS	Contact for details

Quality Control

Our Ramelteon is manufactured under strict quality management systems. Every batch is tested to meet stringent specifications for identity, purity, and potency, ensuring compliance with ICH guidelines and relevant pharmacopeial standards. Comprehensive testing includes assay, related substances, residual solvents, and heavy metals. A detailed Certificate of Analysis (COA) is provided with each shipment to guarantee traceability and batch-to-batch consistency.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time conforms to reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Related Substances (HPLC)	Individual impurity: NMT 0.5% Total impurities: NMT 2.0%
Water (KF)	NMT 1.0%
Residue on Ignition	NMT 0.1%
Heavy Metals	NMT 20 ppm
Residual Solvents (GC)	Complies with ICH Q3C

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