Description

Rivaroxaban Impurity 79 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 process-related impurities. It is an essential material for analytical chemists and quality assurance professionals in pharmaceutical research, development, and manufacturing.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of Rivaroxaban Impurity 79 in active pharmaceutical ingredient (API) and finished drug product analysis.
• Method Development and Validation: Crucial for developing and validating robust analytical methods, such as HPLC and LC-MS, for impurity profiling in compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control (QC) Testing: Used in routine QC laboratories to monitor and control impurity levels during Rivaroxaban API synthesis and formulation to ensure batch-to-batch consistency.
• Stability Studies: Employed as a marker in forced degradation and long-term stability studies to understand the degradation pathways of Rivaroxaban.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing necessary data on impurity characterization and control strategies.
• Process Chemistry Research: Aids chemists in optimizing synthetic routes to minimize the formation of this specific impurity, improving overall process yield and purity.

Basic Information

Product Name	Rivaroxaban Impurity 79
CAS No.	1642601-00-0
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 79; Rivaroxaban EP Impurity H; Rivaroxaban Process Impurity; Xarelto Impurity 79
EINECS	Contact for details

Quality Control

Every batch of Rivaroxaban Impurity 79 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques to ensure compliance with pharmaceutical reference standard requirements. Comprehensive Certificates of Analysis (COA) detailing batch-specific results from HPLC, NMR, and MS are provided to support your regulatory and research needs.

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 should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccants.

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% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
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.