Description

Rivaroxaban Impurity 25 is a high-purity chemical reference standard used in pharmaceutical research and development. This compound is critical for ensuring the quality, safety, and efficacy of the anticoagulant drug Rivaroxaban by serving as a known impurity for analytical method development and validation. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for quality control and compliance purposes. The availability of this well-characterized impurity is essential for meeting stringent pharmacopeial standards and regulatory filings.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Rivaroxaban active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development: Essential for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods to monitor impurity profiles.
• Quality Control & Assurance: Employed in routine QC testing of Rivaroxaban batches to ensure compliance with ICH Q3A/B guidelines and pharmacopeial monographs (USP, EP).
• Stability Studies: Used to track the formation and levels of this specific impurity during forced degradation and long-term stability studies of Rivaroxaban.
• Regulatory Submissions: Provides necessary data for Drug Master Files (DMFs), Investigational New Drug (IND) applications, and New Drug Applications (NDAs).
• Process Chemistry Research: Aids in understanding and optimizing the synthetic pathway of Rivaroxaban to minimize the formation of this impurity.

Basic Information

Product Name	Rivaroxaban Impurity 25
CAS No.	931117-61-2
Molecular Formula	C19H18ClN3O5S
Molecular Weight	435.88 g/mol
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 25; Rivaroxaban EP Impurity G; Rivaroxaban USP Impurity; Rivaroxaban Process Impurity; Xarelto Impurity 25; 4-(4-{[(5S)-5-(Aminomethyl)-2-oxo-1,3-oxazolidin-3-yl]phenyl}morpholin-3-one Impurity
EINECS	Contact for details

Quality Control

Every batch of Rivaroxaban Impurity 25 is manufactured under a quality management system and undergoes rigorous analytical testing to ensure identity, purity, and consistency. Our products are characterized using advanced techniques including HPLC, LC-MS, NMR, and IR spectroscopy. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming compliance with in-house specifications aligned with ICH guidelines. We support regulatory submissions with full traceability and documentation.

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 storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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