Description

Ramelteon Metabolite m-Ii is a key pharmacologically active metabolite of the selective melatonin receptor agonist, Ramelteon. This compound is of critical importance for pharmaceutical research and development, particularly in the study of drug metabolism, pharmacokinetics, and bioanalytical method validation. It serves as an essential reference standard for laboratories in the pharmaceutical and biotechnology sectors, enabling accurate quantification and characterization of Ramelteon and its metabolic pathways in biological matrices.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for quantitative bioanalysis in clinical and preclinical studies.
• Drug Metabolism and Pharmacokinetics (DMPK) Research: Critical for investigating the metabolic fate, clearance, and exposure levels of Ramelteon in vivo.
• Bioanalytical Method Development and Validation: Used to calibrate HPLC, LC-MS, and LC-MS/MS systems for accurate detection and measurement in plasma, serum, and other biological fluids.
• Impurity Profiling and Characterization: Aids in the identification and quantification of metabolic impurities in active pharmaceutical ingredient (API) batches.
• Regulatory Submissions: Supports Investigational New Drug (IND) and New Drug Application (NDA) filings by providing definitive metabolite data to health authorities like the FDA and EMA.
• Toxicology Studies: Employed in safety assessment to understand the profile and potential activity of Ramelteon metabolites.

Basic Information

Product Name	Ramelteon Metabolite m-Ii
CAS No.	896736-21-3
Molecular Formula	C16H21NO2
Molecular Weight	259.35 g/mol
Synonyms	(S)-N-[2-(1,6,7,8-Tetrahydro-2H-indeno[5,4-b]furan-8-yl)ethyl]propionamide; M-II; Ramelteon Metabolite II; (8S)-8-[(2S)-2-Aminopropyl]-5,6,7,8-tetrahydro-1-naphthalenol; TAK-375 Metabolite
EINECS	Contact for details

Quality Control

Every batch of Ramelteon Metabolite m-Ii is manufactured and tested under strict quality management systems. We provide comprehensive analytical data to ensure identity, purity, and strength, meeting the rigorous standards required for pharmaceutical reference materials. A detailed Certificate of Analysis (COA) is supplied with each shipment, documenting results from tests including HPLC purity, chiral purity, residual solvent analysis, and spectroscopic identification (IR, NMR, MS).

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 under dry conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms to reference standard
Identification (IR)	Conforms to structure
Purity (HPLC)	≥98.0%
Chiral Purity (Chiral HPLC)	≥99.0%
Water Content (KF)	≤1.0%
Residual Solvents (GC)	Meets ICH guidelines

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