Description

Rivaroxaban Impurity 20 is a high-purity chemical reference standard used in pharmaceutical research and development. This compound is critical for the quality control and analytical profiling of the anticoagulant drug Rivaroxaban, ensuring product safety and regulatory compliance. It is primarily utilized by pharmaceutical manufacturers, analytical laboratories, and research institutions involved in method development, stability studies, and impurity identification.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the quantitative and qualitative analysis of Rivaroxaban active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Used to develop, optimize, and validate chromatographic methods (e.g., HPLC, UPLC) for impurity detection and quantification.
• Quality Control & Assurance (QC/QA): Essential for routine batch testing to monitor impurity levels and ensure compliance with ICH guidelines and pharmacopeial standards (USP, EP).
• Stability Studies: Employed to identify and track degradation products formed under various stress conditions (e.g., heat, light, humidity) during drug shelf-life studies.
• Regulatory Submissions: Provides necessary impurity characterization data for regulatory filings (e.g., FDA, EMA) to support drug approval processes.
• Research & Development: Used in synthetic chemistry research to study the formation pathways and chemical behavior of this specific impurity.

Basic Information

Product Name	Rivaroxaban Impurity 20
CAS No.	1160170-03-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Rivaroxaban Related Compound 20; Rivaroxaban EP Impurity J; Rivaroxaban USP Impurity; 5-Chloro-N-({(5S)-2-oxo-3-[4-(3-oxomorpholin-4-yl)phenyl]-1,3-oxazolidin-5-yl}methyl)thiophene-2-carboxamide; UNII-9K8F8T8V6T; BAY 59-7939 Impurity 20; Xarelto Impurity 20
EINECS	Contact for details

Quality Control

Our Rivaroxaban Impurity 20 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity confirmation and structural characterization via spectroscopic methods (NMR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. Certificates of Analysis (COA) with detailed chromatographic data are provided to guarantee traceability, identity, and purity for your regulatory and research needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as specified on the certificate of analysis. The material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 95.0%
Single Unknown Impurity (HPLC)	≤ 1.0%
Total Impurities (HPLC)	≤ 5.0%
Water Content (KF)	≤ 2.0%

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