Description

Rivaroxaban Impurity 41 is a designated impurity standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Rivaroxaban. This compound is critical for ensuring the purity, safety, and efficacy of the final drug product by serving as a reference marker in chromatographic methods. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the development, production, and compliance testing of Rivaroxaban-based anticoagulant medications.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of specific impurities in Rivaroxaban API and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating HPLC/UPLC methods to monitor impurity profiles during API synthesis and formulation.
• Quality Control & Batch Release Testing: Employed in routine QC laboratories to ensure that Rivaroxaban batches meet stringent pharmacopeial (e.g., USP, EP) and ICH Q3A/B guidelines for impurity limits.
• Stability Studies: Used to track the formation of this specific degradation product under various stress conditions (e.g., heat, humidity, light) to establish product shelf-life.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to demonstrate comprehensive impurity control.
• Research & Development: Supports process chemistry research to understand and minimize the formation of this impurity during the synthetic pathway of Rivaroxaban.

Basic Information

Product Name	Rivaroxaban Impurity 41
CAS No.	1403383-56-1
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 41; Rivaroxaban Impurity K; Rivaroxaban Chlorothiophene Carboxamide Impurity; UNII-9F8F4S250P; 1403383-56-1; 4-Morpholinecarboxamide, 5-chloro-N-[[(5S)-2-oxo-3-[4-(3-oxo-4-morpholinyl)phenyl]-5-oxazolidinyl]methyl]-2-thiophene-
EINECS	Contact for details

Quality Control

Every batch of Rivaroxaban Impurity 41 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced spectroscopic and chromatographic techniques (HPLC, GC, NMR, MS) to ensure compliance with industry standards for 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 absorption. 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)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
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.