Description

Rivaroxaban Impurity 48 is a high-purity chemical reference standard used in pharmaceutical research and development. This compound is critical for ensuring the safety, efficacy, and regulatory compliance of the anticoagulant drug Rivaroxaban. It is primarily utilized by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and quality control testing. Precise characterization of this impurity is essential for maintaining the highest standards in drug substance and drug product manufacturing.

Application

• Pharmaceutical Reference Standard for Rivaroxaban API and finished product analysis.
• Method Development and Validation in HPLC and LC-MS impurity profiling.
• Quality Control and Batch Release testing for regulatory submissions (e.g., ICH guidelines).
• Stability Studies to monitor impurity formation under various storage conditions.
• Pharmacopoeial Testing to meet USP, EP, or other compendial standards.
• Research and Development for studying the degradation pathways of Rivaroxaban.

Basic Information

Product Name	Rivaroxaban Impurity 48
CAS No.	1414932-72-1
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 48; Rivaroxaban Impurity R; Rivaroxaban Degradant; Rivaroxaban Process Impurity; Xarelto Impurity 48
EINECS	Contact for details

Quality Control

Every batch of Rivaroxaban Impurity 48 is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC, LC-MS, and NMR, to ensure identity, purity, and compliance with industry standards. A comprehensive Certificate of Analysis (COA) detailing all test results is provided with each shipment, supporting your regulatory and quality assurance requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. This material is hygroscopic (moisture-sensitive) and should be handled under appropriate conditions to prevent degradation.

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)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Meets ICH Q3C guidelines

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