Description

Rivaroxaban Impurity 13 CAS NO 1160169-98-1 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 (API) Rivaroxaban, a widely prescribed anticoagulant. It is an essential tool for pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in method development, validation, and impurity profiling. The availability of this well-characterized impurity standard is fundamental for maintaining the stringent quality control required in modern pharmaceutical production.

Application

• Pharmaceutical Impurity Profiling and Identification: Used as a certified reference material for the identification and quantification of specific impurities in Rivaroxaban API and finished drug products.
• Analytical Method Development and Validation: Serves as a critical standard for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for Rivaroxaban analysis.
• Quality Control and Assurance (QC/QA): Employed in routine quality control testing to monitor impurity levels and ensure batch-to-batch consistency and compliance with ICH guidelines.
• Regulatory Submissions and Compliance: Provides essential data for regulatory filings (e.g., with FDA, EMA) to establish impurity thresholds and demonstrate product safety.
• Stability Studies: Used to track the formation of this specific impurity during forced degradation and long-term stability studies of Rivaroxaban formulations.
• Research and Development: Facilitates chemical and pharmacological research to understand the formation, properties, and potential impact of this impurity.

Basic Information

Item	Detail
Product Name	Rivaroxaban Impurity 13
CAS No.	1160169-98-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
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 13; Rivaroxaban EP Impurity J; Rivaroxaban Impurity J; Rivaroxaban Process Impurity; Xarelto Impurity 13
EINECS	Contact for details

Quality Control

Every batch of Rivaroxaban Impurity 13 is manufactured and analyzed under strict quality management systems. The product undergoes comprehensive testing, including identity confirmation by spectroscopic methods (IR, NMR, MS) and purity determination by advanced chromatographic techniques (HPLC, UPLC) to ensure it meets the high 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 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 to ensure stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
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%

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