Description

Rivaroxaban Impurity 15 is a high-purity chemical reference standard used in the pharmaceutical development and quality control of the anticoagulant drug Rivaroxaban. This compound is critical for ensuring the safety and efficacy of the final drug product by enabling the accurate identification, quantification, and control of specific impurities. It is an essential material for analytical laboratories, research institutions, and pharmaceutical manufacturers engaged in method validation, stability studies, and regulatory compliance. The product is supplied with comprehensive analytical data to support its use in GMP environments.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of Rivaroxaban Impurity 15 in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Critical for developing and validating HPLC, UPLC, or LC-MS methods to monitor impurity profiles during drug synthesis and formulation.
• Quality Control & Assurance (QC/QA): Used in routine batch release testing to ensure Rivaroxaban drug substance and drug product meet stringent pharmacopeial (e.g., USP, EP) impurity limits.
• Stability Studies: Employed to track the formation of this specific impurity under various stress conditions (e.g., heat, humidity, light) to establish product shelf-life.
• Regulatory Submissions: Provides essential data for Drug Master Files (DMFs), Investigational New Drug (IND) applications, and New Drug Applications (NDAs) to demonstrate control strategy.
• Process Chemistry Research: Aids chemists in understanding and optimizing the synthetic pathway of Rivaroxaban to minimize the formation of this impurity.

Basic Information

Item	Detail
Product Name	Rivaroxaban Impurity 15
CAS No.	1160169-99-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Rivaroxaban Related Compound 15; Rivaroxaban EP Impurity J; 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-7J3Q8W8B1R; Rivaroxaban Impurity 15 (EP); A specific process-related impurity of Rivaroxaban
EINECS	Contact for details

Quality Control

Every batch of Rivaroxaban Impurity 15 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity analysis, and impurity profiling using advanced techniques such as HPLC, LC-MS, NMR, and IR spectroscopy to ensure it meets the exacting standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, analytical methods, and traceability.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container should be kept in a desiccated environment to prevent moisture uptake, which could affect stability and purity. 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 (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%

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