Description

Darexaban-D3 Maleate is a deuterated isotopologue of the direct Factor Xa inhibitor Darexaban, specifically labeled for use as an internal standard in quantitative bioanalytical methods. This high-purity reference material is critical for ensuring the accuracy and reliability of pharmacokinetic and metabolism studies during drug development. It is primarily utilized by pharmaceutical R&D laboratories, contract research organizations (CROs), and analytical testing facilities specializing in mass spectrometry.

Application

• Primary use as an internal standard for the quantification of Darexaban in biological matrices (e.g., plasma, serum) via LC-MS/MS.
• Supporting pharmacokinetic (PK) and pharmacodynamic (PD) studies in clinical and non-clinical research.
• Method development and validation for bioanalytical assays in accordance with FDA, EMA, and ICH guidelines.
• Metabolite identification and profiling studies in drug metabolism and pharmacokinetics (DMPK).
• Ensuring data integrity and regulatory compliance in Good Laboratory Practice (GLP) environments.
• Quality control and batch analysis within pharmaceutical manufacturing for consistency.

Basic Information

Product Name	Darexaban-D3 Maleate
CAS No.	1346606-64-1
Molecular Formula	C24H23D3N4O5 • C4H4O4
Molecular Weight	Contact for details
Synonyms	YM150-D3 Maleate; Darexaban (deuterated, tri-deuterated); 5-Chloro-N-({(5S)-2-oxo-3-[4-(3-oxomorpholin-4-yl)phenyl]-1,3-oxazolidin-5-yl}methyl)-2-thiophenecarboxamide-d3 Maleate; (5S)-5-({[(5-Chloro-2-thienyl)carbonyl-d3]amino}methyl)-3-[4-(3-oxo-4-morpholinyl)phenyl]-2-oxazolidinone Maleate Salt; Deuterated Darexaban Maleate; Darexaban Internal Standard
EINECS	Contact for details

Quality Control

Our Darexaban-D3 Maleate is manufactured under strict quality systems to ensure the high chemical and isotopic purity required for analytical applications. Each batch is supported by a comprehensive Certificate of Analysis (COA) detailing results for identity, purity (by HPLC), isotopic enrichment, and other critical parameters. We adhere to relevant industry standards to guarantee reproducibility and traceability for your research.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. This compound is hygroscopic (moisture-sensitive); keep the container tightly sealed in a dry environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC/MS)	Conforms
Purity (HPLC)	≥98.0%
Isotopic Purity (deuterium)	≥99.0 atom % D
Chemical Purity (by HPLC)	≥95.0%
Water Content (KF)	≤1.0%
Residual Solvents (GC)	Complies with ICH limits

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