Description

Rivaroxaban Related Compound (R-4-(4-(5-(Aminomethyl)-2-Oxooxazolidin-3-Yl)Phenyl-Morpholin-3-One Hcl) is a high-purity chemical reference standard, specifically a process-related impurity of the anticoagulant drug Rivaroxaban. This compound is critical for pharmaceutical research, development, and quality control, enabling the accurate identification, quantification, and monitoring of this specific impurity during drug substance manufacturing. It is an essential material for analytical chemists and quality assurance professionals in the pharmaceutical industry who require reliable reference standards to ensure drug safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Impurity Profiling and Characterization: Used as a certified reference standard for the identification and quantification of the R-enantiomer-related impurity in Rivaroxaban active pharmaceutical ingredient (API) batches.
• Analytical Method Development and Validation: Serves as a critical component in developing and validating stability-indicating HPLC, UPLC, or LC-MS methods for Rivaroxaban.
• Quality Control (QC) and Quality Assurance (QA): Employed in routine QC testing to monitor impurity levels against International Council for Harmonisation (ICH) guidelines, ensuring final drug product purity.
• Regulatory Submissions and Compliance: Provides essential data for regulatory filings (e.g., with FDA, EMA) to demonstrate thorough impurity control strategies for Rivaroxaban.
• Stability Studies: Used as a marker in forced degradation and long-term stability studies of Rivaroxaban to understand degradation pathways.
• Pharmacological Research: Acts as a tool in comparative studies to understand the structure-activity relationship (SAR) and the pharmacological impact of specific stereoisomers or related compounds.

Basic Information

Item	Details
Product Name	Rivaroxaban Related Compound (R-4-(4-(5-(Aminomethyl)-2-Oxooxazolidin-3-Yl)Phenyl-Morpholin-3-One Hcl)
CAS No.	1429311-47-6
Molecular Formula	C19H25ClN4O5
Molecular Weight	424.88 g/mol
Synonyms	Rivaroxaban Impurity; Rivaroxaban Related Substance; (R)-5-Chloro-N-({(5S)-2-oxo-3-[4-(3-oxomorpholin-4-yl)phenyl]-1,3-oxazolidin-5-yl}methyl)thiophene-2-carboxamide Hydrochloride; Rivaroxaban Enantiomer Impurity; BAY 59-7939 Related Compound; Rivaroxaban HCl Impurity; 4-(4-((5R)-5-(Aminomethyl)-2-oxo-1,3-oxazolidin-3-yl)phenyl)morpholin-3-one hydrochloride
EINECS	Contact for details

Quality Control

Every batch of our Rivaroxaban Related Compound is manufactured and analyzed under strict quality management systems. We provide comprehensive analytical data to support its use as a reference standard, including characterization by advanced spectroscopic techniques. A detailed Certificate of Analysis (COA) is supplied with each lot, reporting results for identity, purity (by HPLC), and specified impurities. Our quality commitment ensures the material meets the stringent requirements for pharmaceutical impurity standards, supporting compliance with ICH Q3A, Q3B, and cGMP guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This compound is hygroscopic (moisture-sensitive); therefore, the container must be kept tightly sealed in a dry environment to prevent absorption of moisture. 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 (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Any individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
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.