Description

Rivaroxaban Impurity 28 is a designated process-related impurity or degradation product of the anticoagulant active pharmaceutical ingredient (API) Rivaroxaban. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development, validation, and quality control. It is essential for manufacturers and analytical laboratories engaged in the synthesis, purification, and regulatory compliance of Rivaroxaban to ensure the safety and efficacy of the final drug product.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Rivaroxaban API and finished dosage forms.
• Analytical Method Development: Critical for developing and validating HPLC, UPLC, or LC-MS methods to monitor impurity profiles during API synthesis and formulation.
• Quality Control & Assurance: Employed in routine batch release testing to ensure Rivaroxaban meets stringent pharmacopeial (e.g., USP, EP) and ICH Q3A/B guidelines for impurity limits.
• Stability Studies: Used to track the formation of degradation products under various stress conditions (light, heat, humidity) to establish product shelf-life.
• Process Chemistry Research: Aids in understanding and optimizing the synthetic pathway of Rivaroxaban to minimize the formation of this specific impurity.
• Regulatory Submissions: Provides essential data for Drug Master Files (DMFs), Investigational New Drug (IND), and New Drug Application (NDA) submissions to health authorities like the FDA and EMA.

Basic Information

Product Name	Rivaroxaban Impurity 28
CAS No.	2489689-18-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Rivaroxaban Related Compound 28; Rivaroxaban EP Impurity M; 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; UNII-7K8V5L8A4T; BAY 59-7939 Impurity 28; Xarelto Impurity 28
EINECS	Contact for details

Quality Control

Every batch of Rivaroxaban Impurity 28 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced chromatographic (HPLC, UPLC) and spectroscopic (NMR, MS) techniques to ensure compliance with industry standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. The material is hygroscopic (moisture-sensitive) and should be handled in a dry environment 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 spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0% w/w

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