Description

Rivaroxaban Impurity 93 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient (API) Rivaroxaban, a widely prescribed anticoagulant. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling studies. The availability of this well-characterized impurity standard is essential for maintaining stringent quality control in pharmaceutical production.

Application

• Pharmaceutical Impurity Profiling and Identification: Used as a certified reference material (CRM) to identify, quantify, and monitor Rivaroxaban Impurity 93 during API and finished drug product development and manufacturing.
• Analytical Method Development and Validation: Serves as a critical standard for developing, optimizing, and validating chromatographic methods, such as HPLC and UPLC, for impurity detection.
• Quality Control and Assurance (QC/QA): Employed in routine quality control testing to ensure Rivaroxaban batches meet stringent pharmacopeial (e.g., USP, EP) and internal purity specifications.
• Stability Studies: Used to track the formation and level of this specific impurity under various stress conditions to determine drug product shelf-life.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., with FDA, EMA) to demonstrate comprehensive impurity control strategies.
• Research and Development: Facilitates research into the synthesis pathways, degradation mechanisms, and toxicological profiles of Rivaroxaban-related substances.

Basic Information

Product Name	Rivaroxaban Impurity 93
CAS No.	1424944-35-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Rivaroxaban Related Compound 93; 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-9I1719I71F; Rivaroxaban Impurity (Rivaroxaban EP Impurity J); A specific process-related impurity of Rivaroxaban
EINECS	Contact for details

Quality Control

Our Rivaroxaban Impurity 93 is manufactured under controlled conditions and undergoes rigorous, multi-stage analytical testing to ensure identity, purity, and consistency. Each batch is characterized using advanced techniques including HPLC, MS, and NMR. We provide comprehensive Certificates of Analysis (COA) with detailed chromatographic and spectroscopic data, supporting compliance with ICH Q3A/B guidelines and pharmacopeial standards for impurity reference materials.

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 material is hygroscopic (moisture-sensitive) and must be kept under inert conditions or in a desiccator to prevent degradation upon exposure to atmospheric humidity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (MS)	Mass spectrum conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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