Description

Rivaroxaban Impurity 59 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of the active pharmaceutical ingredient (API) Rivaroxaban, a widely prescribed anticoagulant. It is primarily utilized by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and quality control testing. The availability of this well-characterized impurity is essential for compliance with stringent pharmacopeial guidelines and regulatory submissions.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Rivaroxaban Impurity 59 in drug substance and finished product analysis.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC/UPLC methods to monitor impurity profiles during stability studies.
• Quality Control & Assurance (QC/QA): Serves as a system suitability standard and for setting specification limits in the release testing of Rivaroxaban API and formulations.
• Regulatory Compliance & Filings: Supports the preparation of regulatory documents (e.g., CMC sections for FDA, EMA) by providing necessary impurity characterization data.
• Stability Studies: Employed to track the formation and growth of this specific impurity under various stress conditions (heat, light, humidity).
• Research & Development: Used in R&D laboratories to study the degradation pathways and chemistry of Rivaroxaban.

Basic Information

Product Name	Rivaroxaban Impurity 59
CAS No.	1498-66-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Rivaroxaban Related Compound 59; 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; BAY 59-7939 Impurity 59; Xarelto Impurity 59
EINECS	Contact for details

Quality Control

Our Rivaroxaban Impurity 59 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including identification by spectroscopic methods (IR, NMR, MS), purity determination by HPLC, and control of related substances. A detailed Certificate of Analysis (COA) is provided with each shipment, confirming compliance with in-house specifications aligned with ICH Q3A/B guidelines. We support our clients' needs for regulatory filings with comprehensive characterization data.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the certificate of analysis. The material should be kept in a dry environment to prevent moisture uptake. For long-term storage, consider storing under inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Conforms to reference spectrum
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.