Description

Rivaroxaban Impurity 22 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for pharmaceutical quality control, enabling the accurate identification and quantification of process-related impurities in Rivaroxaban, a leading anticoagulant API. It is an essential material for analytical chemists and quality assurance professionals in pharmaceutical development and manufacturing. Ensuring the purity and traceability of such impurities is fundamental to meeting stringent global regulatory requirements for drug safety and efficacy.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of impurities in Rivaroxaban Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Used to develop, optimize, and validate sensitive HPLC, UPLC, or LC-MS/MS methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Serves as a system suitability standard and for routine batch release testing in GMP-compliant pharmaceutical manufacturing facilities.
• Stability Studies: Employed to monitor the formation of degradation products in Rivaroxaban under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to agencies like the FDA and EMA.
• Research & Development: Used in academic and industrial R&D to study the synthesis pathway, degradation mechanisms, and metabolic pathways of Rivaroxaban.

Basic Information

Product Name	Rivaroxaban Impurity 22
CAS No.	1350288-77-5
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 22; Rivaroxaban Impurity B; Rivaroxaban EP Impurity B; Rivaroxaban USP Impurity; Xarelto Impurity 22
EINECS	Contact for details

Quality Control

Every batch of Rivaroxaban Impurity 22 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced chromatographic (HPLC, UPLC) and spectroscopic (NMR, MS) techniques to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for identity, assay, purity, and related substances. We support regulatory filings with full traceability and stability data.

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)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Any individual impurity ≤ 0.5% Total impurities ≤ 1.0%
Water Content (KF)	≤ 0.5%
Residue on Ignition	≤ 0.1%

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