Description

Rivaroxaban-D4 CAS NO 1132681-38-9 is a deuterium-labeled internal standard of the direct Factor Xa inhibitor, Rivaroxaban, specifically designed for use in quantitative analytical methods. This high-purity reference material is critical for ensuring accuracy and reliability in pharmacokinetic and bioanalytical studies. It is an essential tool for pharmaceutical R&D laboratories, clinical research organizations, and quality control departments involved in the development and monitoring of anticoagulant therapies.

Application

• Quantitative Bioanalysis: Serves as a stable isotope-labeled internal standard in Liquid Chromatography-Mass Spectrometry (LC-MS/MS) for the precise quantification of Rivaroxaban in biological matrices such as plasma, serum, and urine.
• Pharmacokinetic/Pharmacodynamic (PK/PD) Studies: Enables accurate measurement of drug concentration-time profiles, supporting critical studies on absorption, distribution, metabolism, and excretion (ADME).
• Clinical Trial Support: Used in the bioanalytical method development and validation required for Phase I-IV clinical trials of Rivaroxaban and its formulations.
• Drug Metabolism Research: Facilitates studies on the metabolic pathways and stability of Rivaroxaban in vitro and in vivo.
• Quality Control & Method Validation: Essential for developing and validating robust, regulatory-compliant analytical methods within pharmaceutical quality control laboratories.
• Forensic and Toxicology Analysis: Aids in the accurate detection and quantification of Rivaroxaban in forensic investigations or cases of suspected overdose.

Basic Information

Product Name	Rivaroxaban-D4
CAS No.	1132681-38-9
Molecular Formula	C19H14D4Cl2N3O5S
Molecular Weight	471.35 g/mol (for C19H14D4Cl2N3O5S)
Synonyms	Rivaroxaban-d4; 5-Chloro-N-({(5S)-2-oxo-3-[4-(3-oxomorpholin-4-yl)phenyl]-1,3-oxazolidin-5-yl}methyl)thiophene-2-carboxamide-d4; Xarelto-d4; BAY 59-7939-d4; Rivaroxaban (D4); Deuterated Rivaroxaban; Rivaroxaban Internal Standard
EINECS	Contact for details

Quality Control

Our Rivaroxaban-D4 is manufactured under strict quality systems to ensure the high purity and isotopic enrichment required for sensitive analytical applications. Each batch undergoes comprehensive testing, including HPLC for chemical purity, NMR and MS for structural confirmation and isotopic enrichment, and residual solvent analysis. A detailed Certificate of Analysis (COA) is provided with each shipment, documenting batch-specific results. Our quality commitment supports compliance with ICH Q2(R1) guidelines for analytical method validation.

Storage

Preserve in a tightly closed container, protected from light. Store at -20°C or below in a dedicated freezer. This product is hygroscopic (moisture-sensitive). Allow the sealed vial to equilibrate to 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 solid
Identification (HPLC)	Conforms to reference standard
Identification (MS)	Conforms to reference standard
Purity (HPLC)	≥ 98.0%
Isotopic Purity (Deuterium Enrichment)	≥ 98.0 atom % D
Chemical Purity	≥ 95.0%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C

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