Description

Rivaroxaban Impurity 49 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, ensuring product safety and efficacy. It is primarily required by analytical laboratories, pharmaceutical manufacturers, and regulatory bodies for method validation, impurity profiling, and stability studies.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of related substances in Rivaroxaban Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development and Validation: Essential for developing and validating chromatographic methods (HPLC, UPLC) to monitor impurity levels during drug manufacturing.
• Stability Indicating Studies: Employed in forced degradation and long-term stability studies to track the formation of this specific impurity under various stress conditions.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to meet FDA, EMA, and ICH guidelines.
• Quality Control (QC) Testing: Serves as a system suitability and calibration standard in routine QC testing of Rivaroxaban batches to ensure they meet pharmacopeial specifications.
• Research and Development: Used in synthetic chemistry research to study the formation pathway and chemical behavior of this impurity.

Basic Information

Item	Details
Product Name	Rivaroxaban Impurity 49
CAS No.	2206360-84-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Rivaroxaban Related Compound 49; Rivaroxaban Impurity 49 (EP); Rivaroxaban EP Impurity I; 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-Contact for details; Xarelto Impurity 49
EINECS	Contact for details

Quality Control

Our Rivaroxaban Impurity 49 is manufactured under strict quality management systems. Each batch is characterized and tested using advanced analytical techniques to ensure identity, purity, and stability. We provide comprehensive Certificates of Analysis (COA) that include data from HPLC, NMR, and MS, supporting compliance with ICH Q3A, Q3B, and relevant pharmacopeial guidelines (USP, EP).

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. This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Mass spectrum conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

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