Description

Rac Ramelteon-D3 is a deuterated isotopologue of the melatonin receptor agonist Ramelteon, specifically designed for use as an internal standard in analytical chemistry. This high-purity reference material is critical for ensuring the accuracy and reliability of quantitative analyses, particularly in pharmacokinetic and metabolic studies. It is an essential tool for pharmaceutical R&D laboratories, contract research organizations (CROs), and quality control units requiring precise measurement of Ramelteon and its metabolites.

Application

• Internal Standard for LC-MS/MS: Primary application as a stable, isotopically labeled internal standard for the quantitative bioanalysis of Ramelteon in biological matrices (plasma, serum, tissue).
• Pharmaceutical Research & Development: Used in method development and validation for drug metabolism and pharmacokinetics (DMPK) studies during preclinical and clinical trials.
• Forensic and Clinical Toxicology: Enables accurate quantification of Ramelteon in forensic analysis and therapeutic drug monitoring (TDM) programs.
• Metabolite Identification Studies: Aids in the identification and characterization of Ramelteon metabolites using mass spectrometry.
• Quality Control & Assurance: Serves as a critical reference compound for in-house QC methods to ensure the purity and potency of Ramelteon active pharmaceutical ingredient (API) and finished dosage forms.
• Regulatory Submissions: Supports the generation of robust analytical data required for regulatory filings with agencies like the FDA and EMA.

Basic Information

Product Name	Rac Ramelteon-D3
CAS No.	1185146-24-0
Molecular Formula	C16H18D3NO2
Molecular Weight	262.37 g/mol
Synonyms	(±)-Ramelteon-D3; Rac-Ramelteon-d3; Ramelteon (D3, Racemic); (S)-N-[2-(1,6,7,8-Tetrahydro-2H-indeno[5,4-b]furan-8-yl)ethyl]propionamide-d3; TAK-375-D3; Rozerem-D3; Deuterated Ramelteon Racemate; Melatonin Receptor Agonist D3 Standard
EINECS	Contact for details

Quality Control

Every batch of Rac Ramelteon-D3 is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure identity, purity, and isotopic enrichment. Our quality system is designed to meet the exacting standards of analytical reference material users. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results for assay, isotopic purity, and related substances by HPLC and LC-MS. We support compliance with cGMP and ISO 17034 (Reference Material Producer) guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at 2-8°C in a dry, cool place. Due to its hygroscopic nature, the container should be allowed to reach room temperature before opening to minimize moisture uptake. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Purity (D3)	≥ 98.0 atom % D
Chemical Purity (NMR)	Conforms
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.