Description

Rivaroxaban Impurity 26 is a high-purity chemical reference standard used in pharmaceutical research and development. This compound is critical for the quality control and regulatory compliance of the anticoagulant drug Rivaroxaban. It is primarily required by analytical laboratories and pharmaceutical manufacturers for method development, validation, and impurity profiling studies. Ensuring a reliable supply of this well-characterized impurity is essential for maintaining drug safety and efficacy.

Application

• Pharmaceutical Reference Standard for the identification and quantification of impurities in Rivaroxaban Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Analytical Method Development and Validation in Quality Control (QC) laboratories to establish accurate HPLC/UPLC or LC-MS methods.
• Stability Studies and forced degradation studies to monitor impurity formation under various stress conditions.
• Regulatory Submissions to agencies like the FDA and EMA, providing essential data for drug approval and market authorization.
• Process Chemistry Research to understand and control the formation of this impurity during the synthesis of Rivaroxaban.
• Academic and Contract Research focused on the metabolism, pharmacokinetics, and safety profile of Rivaroxaban.

Basic Information

Product Name	Rivaroxaban Impurity 26
CAS No.	1838133-00-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Rivaroxaban Related Compound 26; Rivaroxaban EP Impurity 26; Rivaroxaban USP Impurity 26; 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 (IUPAC); Xarelto Impurity 26; BAY 59-7939 Impurity 26
EINECS	Contact for details

Quality Control

Every batch of Rivaroxaban Impurity 26 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous testing to ensure identity, purity, and consistency, aligning with pharmacopeial expectations for reference standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results from advanced analytical techniques such as HPLC, LC-MS, and NMR. We support compliance with ICH Q3A/B, USP, and EP guidelines for impurities in new drug substances.

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 dry conditions to maintain stability and purity. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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