Description

Ramelteon Metabolite m-II-D3 (Mixture Of R And S At The Hydroxy Position) is a deuterium-labeled internal standard critical for the precise bioanalytical quantification of ramelteon and its metabolites. This high-purity reference material is essential for ensuring accuracy and reproducibility in pharmacokinetic and metabolism studies. It is primarily required by pharmaceutical R&D laboratories, contract research organizations (CROs), and analytical testing facilities engaged in drug development and regulatory compliance.

Application

• Bioanalytical Method Development & Validation: Serves as a stable isotope-labeled internal standard for Liquid Chromatography-Mass Spectrometry (LC-MS/MS) assays.
• Pharmacokinetic (PK) Studies: Enables accurate quantification of ramelteon metabolite levels in biological matrices (plasma, serum, urine) for ADME profiling.
• Clinical Trial Support: Used in the bioanalysis phase of clinical trials to monitor drug metabolism and ensure reliable data for regulatory submissions.
• Forensic & Doping Control Analysis: Supports precise identification and quantification in specialized toxicology screening.
• Metabolite Identification & Characterization: Aids in structural confirmation and pathway elucidation during drug metabolism research.
• Quality Control in Reference Standard Production: Acts as a calibrant for ensuring the purity and potency of related pharmaceutical standards.

Basic Information

Product Name	Ramelteon Metabolite m-II-D3 (Mixture Of R And S At The Hydroxy Position)
CAS No.	1246812-22-5
Molecular Formula	C16H18D3NO2
Molecular Weight	262.38 g/mol (approx.)
Synonyms	Ramelteon D3 Metabolite M-II; (S)-N-[2-[(8S)-1,6,7,8-Tetrahydro-2H-indeno[5,4-b]furan-8-yl]ethyl]propionamide-d3 (hydroxy mixture); Ramelteon Hydroxy Metabolite D3; m-II-D3 Ramelteon; Deuterated Ramelteon Metabolite; Ramelteon metabolite (M-II) D3 (R/S mixture at OH); 8-Hydroxy Ramelteon-d3 (diastereomeric mixture)
EINECS	Contact for details

Quality Control

Every batch of Ramelteon Metabolite m-II-D3 is manufactured and analyzed under strict quality management systems. We provide comprehensive analytical data to support its use in regulated environments. A Certificate of Analysis (COA) is supplied with each shipment, detailing purity (typically ≥95% by HPLC), isotopic enrichment, and confirming structural identity via spectroscopic methods. Our quality protocols are designed to meet the stringent requirements of pharmaceutical reference standard applications.

Storage

Preserve in a tightly closed container, protected from light. Store at -20°C or below in a freezer. This product is hygroscopic (moisture-sensitive); ensure the container is sealed under inert atmosphere after each use to maintain stability and prevent degradation. Allow the sealed vial to equilibrate to room temperature before opening to minimize moisture ingress.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (Mass Spec)	Conforms to structure
Purity (HPLC)	≥ 95.0%
Isotopic Purity (D3)	≥ 98 atom % D
Chemical Purity (HPLC)	≥ 98.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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