Description

Rivaroxaban Impurity 21 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 Rivaroxaban, a widely prescribed anticoagulant. It is an essential material for pharmaceutical manufacturers, analytical laboratories, and research institutions engaged in method development, stability studies, and impurity profiling to meet stringent pharmacopeial standards.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference standard for the identification and quantification of specific impurities in Rivaroxaban API and finished dosage forms.
• Analytical Method Development & Validation: Serves as a critical component in developing and validating HPLC, UPLC, or LC-MS methods for impurity detection.
• Quality Control & Assurance (QC/QA): Employed in routine quality control testing to monitor impurity levels and ensure batch-to-batch consistency of Rivaroxaban.
• Stability Studies: Used to track the formation of this impurity during forced degradation and long-term stability studies of Rivaroxaban products.
• Regulatory Compliance & Filings: Essential for preparing regulatory documentation (e.g., for FDA, EMA) to establish impurity thresholds and control strategies.
• Research & Development: Utilized in pharmaceutical R&D to study the degradation pathways and chemical behavior of Rivaroxaban.

Basic Information

Product Name	Rivaroxaban Impurity 21
CAS No.	1328136-38-4
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 21; Rivaroxaban Impurity O; Rivaroxaban EP Impurity I; Rivaroxaban USP Impurity; Xarelto Impurity 21; 4-(4-{(5S)-5-[(5-Chlorothiophene-2-amido)methyl]-2-oxo-1,3-oxazolidin-3-yl}phenyl)morpholin-3-one
EINECS	Contact for details

Quality Control

Every batch of Rivaroxaban Impurity 21 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced techniques like HPLC, LC-MS, and NMR to ensure compliance with pharmacopeial standards (USP, EP) and customer specifications. A comprehensive Certificate of Analysis (COA) detailing all test results is provided with each shipment.

Storage

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

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
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.