Description

Rivaroxaban Impurity 118 is a high-purity chemical reference standard used in the pharmaceutical development and quality control of the anticoagulant drug Rivaroxaban. This impurity is critical for ensuring the safety, efficacy, and regulatory compliance of the final drug product by enabling accurate identification and quantification of related substances. It is an essential material for analytical laboratories, quality assurance departments, and research institutions within the global pharmaceutical and contract research organization (CRO) sectors.

Application

• Pharmaceutical Impurity Profiling and Characterization: Serves as a certified reference material for the identification and structural elucidation of process-related impurities in Rivaroxaban API.
• Analytical Method Development and Validation: Used as a critical standard to develop, optimize, and validate HPLC, UPLC, or LC-MS methods for impurity detection and quantification.
• Quality Control (QC) and Stability Testing: Employed in routine batch release testing and stability studies to monitor impurity levels and ensure they remain within ICH (Q3A, Q3B) specified limits.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., with FDA, EMA) to demonstrate comprehensive impurity control and drug safety.
• Research and Development: Used in synthetic chemistry research to study degradation pathways and to develop improved purification processes for Rivaroxaban.

Basic Information

Product Name	Rivaroxaban Impurity 118
CAS No.	1838139-24-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Rivaroxaban Related Compound 118; Rivaroxaban Impurity O; Rivaroxaban EP Impurity H; 5-Chloro-N-({(5S)-2-oxo-3-[4-(3-oxomorpholin-4-yl)phenyl]-1,3-oxazolidin-5-yl}methyl)thiophene-2-carboxamide; UNII-9J8P1C7Q6F; Rivaroxaban Impurity 118 (EP); Rivaroxaban Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Rivaroxaban Impurity 118 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing, including advanced chromatographic and spectroscopic techniques, to ensure compliance with pharmacopeial standards and customer specifications. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing purity, identity, and impurity profile.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption, which may affect stability and purity.

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)	Individual unknown impurity ≤ 0.5% Total impurities ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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