Description

Rivaroxaban Impurity 57 is a high-purity chemical reference standard used in pharmaceutical research and development. This compound is critical for ensuring the quality, safety, and efficacy of the anticoagulant drug Rivaroxaban by serving as a known impurity for analytical method development and validation. It is an essential material for analytical chemists and quality control laboratories within the pharmaceutical and biotechnology sectors, particularly those involved in API manufacturing and regulatory compliance.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in Rivaroxaban active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development: Serves as a critical standard for developing, optimizing, and validating HPLC, UPLC, and LC-MS methods to monitor impurity levels.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to ensure Rivaroxaban meets stringent pharmacopeial standards (e.g., USP, EP, ICH Q3A/B guidelines) for impurity limits.
• Stability Studies: Used to track the formation of degradation products under various stress conditions, supporting drug shelf-life determination.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to demonstrate comprehensive impurity control and characterization.
• Research & Development: Facilitates studies on the synthesis pathway, degradation pathways, and metabolic profiling of Rivaroxaban.

Basic Information

Product Name	Rivaroxaban Impurity 57
CAS No.	20406-73-9
Molecular Formula	C19H18ClN3O5S
Molecular Weight	435.88 g/mol
Synonyms	5-Chloro-N-({(5S)-2-oxo-3-[4-(3-oxomorpholin-4-yl)phenyl]-1,3-oxazolidin-5-yl}methyl)thiophene-2-carboxamide; Rivaroxaban Related Compound 57; Rivaroxaban EP Impurity G; Rivaroxaban USP Impurity; Xarelto Impurity 57; 4-(4-{[(5S)-5-(Aminomethyl)-2-oxo-1,3-oxazolidin-3-yl]phenyl}morpholin-3-one Impurity; 5-Chlorothiophene-2-carboxamide derivative of Rivaroxaban intermediate
EINECS	Contact for details

Quality Control

Every batch of Rivaroxaban Impurity 57 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing to ensure compliance with industry standards, including ICH guidelines. Comprehensive characterization is performed using advanced techniques (HPLC, GC, MS, NMR, IR). Certificates of Analysis (COA) are provided with each shipment, detailing purity, identity, and impurity profile.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. Keep the container in a dry, cool, and well-ventilated area. For long-term storage, consider storing under inert atmosphere to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5%
Heavy Metals	≤ 20 ppm

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