Description

Rivaroxaban Impurity CAS NO 1616563-62-2 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.

Application

• Pharmaceutical Impurity Profiling and Identification: Used as a certified reference material to identify, quantify, and monitor this specific impurity during Rivaroxaban API manufacturing and quality control.
• Analytical Method Development and Validation: Serves as a critical standard for developing and validating HPLC, UPLC, or LC-MS methods to ensure accurate detection and quantification limits.
• Stability Studies and Forced Degradation Testing: Employed to understand the degradation pathways of Rivaroxaban and to establish appropriate shelf-life and storage conditions for the final drug product.
• Regulatory Compliance and Documentation: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) to demonstrate comprehensive impurity control and adherence to ICH Q3A/B guidelines.
• Quality Control and Batch Release Testing: Used in routine QC laboratories to confirm that Rivaroxaban API and finished drug products meet stringent purity specifications.
• Research and Development: Supports ongoing R&D efforts to improve synthetic routes, purification processes, and overall understanding of Rivaroxaban's chemical behavior.

Basic Information

Product Name	Rivaroxaban Impurity
CAS No.	1616563-62-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Rivaroxaban Related Compound; Rivaroxaban Process Impurity; 5-Chloro-N-({(5S)-2-oxo-3-[4-(3-oxomorpholin-4-yl)phenyl]-1,3-oxazolidin-5-yl}methyl)thiophene-2-carboxamide; UNII-8VU5L8K0Q5; Rivaroxaban Impurity 14; Rivaroxaban EP Impurity G; (5S)-5-({[(5-Chlorothiophen-2-yl)carbonyl]amino}methyl)-3-[4-(3-oxo-4-morpholinyl)phenyl]-2-oxazolidinone
EINECS	Contact for details

Quality Control

Every batch of Rivaroxaban Impurity CAS 1616563-62-2 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced chromatographic (HPLC, LC-MS) and spectroscopic techniques to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment to support your regulatory and quality assurance requirements.

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 maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 0.5% Total impurities ≤ 1.0%
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.