Description

Rivaroxaban Impurity A CAS NO 931204-39-6 is a specified impurity of the active pharmaceutical ingredient (API) Rivaroxaban, a direct Factor Xa inhibitor. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development, validation, and quality control. It is essential for scientists and quality assurance professionals in the pharmaceutical industry who require high-purity chemical standards to ensure the safety, efficacy, and regulatory compliance of Rivaroxaban-based drug products.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Rivaroxaban Impurity A in API and finished dosage forms.
• Analytical Method Development: Crucial for developing and optimizing chromatographic methods, such as HPLC and UPLC, for impurity profiling.
• Quality Control & Assurance (QC/QA): Used in routine batch testing to monitor impurity levels and ensure product specifications are met according to ICH guidelines.
• Regulatory Compliance & Filing: Supports the preparation of regulatory submission documents (e.g., for FDA, EMA) by providing necessary impurity characterization data.
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions.
• Research & Development: Used in synthetic chemistry research to study the formation pathways and chemical behavior of this impurity.

Basic Information

Product Name	Rivaroxaban Impurity A
CAS No.	931204-39-6
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 A; Rivaroxaban EP Impurity A; Rivaroxaban USP Impurity A; BAY 59-7939 Impurity A; Xarelto Impurity A; 4-(4-{[(5S)-5-(Aminomethyl)-2-oxo-1,3-oxazolidin-3-yl]phenyl}morpholin-3-one Impurity
EINECS	Contact for details

Quality Control

Our Rivaroxaban Impurity A is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure it meets the high-purity standards required for pharmaceutical reference materials. Each batch is characterized using advanced techniques including HPLC, MS, and NMR. A comprehensive Certificate of Analysis (COA) is provided, detailing purity, identity, and impurity profile, supporting compliance with ICH Q3A/B, USP, and EP guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°F). This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Any individual impurity ≤ 0.5% Total impurities ≤ 1.0%
Water Content (KF)	≤ 0.5%
Residue on Ignition	≤ 0.1%

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