Description

Rivaroxaban Impurity 27 CAS NO 1369969-44-7 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 an essential tool for pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in method development, validation, and impurity profiling. The availability of this well-characterized impurity standard is fundamental for maintaining stringent quality control in pharmaceutical production.

Application

• Pharmaceutical Impurity Profiling and Identification: Used as a certified reference material for the identification and quantification of specific impurities in Rivaroxaban API and finished drug products.
• Analytical Method Development and Validation: Serves as a critical standard for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for impurity analysis.
• Quality Control and Assurance (QC/QA): Employed in routine batch release testing to ensure Rivaroxaban products meet pharmacopeial (e.g., USP, EP) and internal purity specifications.
• Stability Studies: Used to monitor the formation of degradation products in Rivaroxaban formulations under various stress conditions (e.g., heat, light, humidity).
• Regulatory Compliance and Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to establish impurity thresholds and justify specifications.
• Research and Development: Facilitates studies on the synthesis pathways, degradation mechanisms, and toxicological assessment of Rivaroxaban-related compounds.

Basic Information

Product Name	Rivaroxaban Impurity 27
CAS No.	1369969-44-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Rivaroxaban Related Compound 27; Rivaroxaban EP Impurity G; 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; Xarelto Impurity 27; BAY 59-7939 Impurity 27; (5S)-5-({[(5-Chlorothiophen-2-yl)carbonyl]amino}methyl)-3-[4-(3-oxomorpholin-4-yl)phenyl]-1,3-oxazolidin-2-one
EINECS	Contact for details

Quality Control

Our Rivaroxaban Impurity 27 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including advanced chromatographic and spectroscopic techniques, to ensure identity, purity, and consistency. We provide comprehensive Certificates of Analysis (COA) with detailed test results, ensuring full traceability and compliance with current industry standards for reference materials. Specifications are aligned with the requirements of major pharmacopeias.

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); the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

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)	Total impurities ≤ 2.0% Any individual unspecified impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0%

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