Description

5A€-[(Desloratadine)Methyl] Rupatadine-D8 is a high-purity, deuterium-labeled internal standard critical for advanced analytical applications. This compound is essential for ensuring the accuracy and reliability of quantitative bioanalytical methods, particularly in pharmacokinetic and metabolism studies. It is primarily needed by pharmaceutical R&D laboratories, contract research organizations (CROs), and analytical service providers engaged in the development and validation of assays for the antihistamine drug Rupatadine and its metabolites.

Application

• Used as a deuterated internal standard in Liquid Chromatography-Mass Spectrometry (LC-MS/MS) for the precise quantification of Rupatadine in biological matrices.
• Critical for conducting pharmacokinetic (PK) and bioavailability studies in drug development and clinical trials.
• Enables accurate metabolite profiling and identification studies in drug metabolism and pharmacokinetics (DMPK) research.
• Supports bioanalytical method development and validation to meet regulatory standards (e.g., FDA, EMA).
• Facilitates therapeutic drug monitoring (TDM) and forensic toxicology analysis.
• Employed in stable isotope dilution analysis to achieve superior accuracy and precision over conventional internal standards.

Basic Information

Product Name	5A€-[(Desloratadine)Methyl] Rupatadine-D8
CAS No.	1794669-33-2
Molecular Formula	C26H18D8ClN3
Molecular Weight	Approx. 423.99 g/mol
Synonyms	Rupatadine-d8; Deuterated Rupatadine; 8-Chloro-6,11-dihydro-11-[1-[(5-methyl-3-pyridinyl)methyl]-4-piperidinylidene]-5H-benzo[5,6]cyclohepta[1,2-b]pyridine-d8; 5A€-[(Desloratadine-8-d8)Methyl] Rupatadine; Rupatadine (methyl-d8) internal standard
EINECS	Contact for details

Quality Control

Our deuterated standards are manufactured under strict quality control protocols to ensure isotopic purity and chemical integrity. Each batch is analyzed using advanced techniques including NMR and High-Resolution Mass Spectrometry (HRMS) to confirm deuteration level and identity. A comprehensive Certificate of Analysis (COA) is provided, detailing purity (by HPLC), isotopic enrichment, and other critical specifications to support your regulatory submissions.

Storage

Preserve in a tightly closed container, protected from light. Store at -20°C or below in a dry, cool place. This product is hygroscopic (moisture-sensitive). For long-term storage, consider storage under an inert atmosphere to ensure stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (NMR)	Conforms to structure
Identification (HRMS)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Purity (D8)	≥ 98.0 atom % D
Water Content (KF)	≤ 0.5%
Residual Solvents (GC)	Meets ICH guidelines

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