Description

Rivaroxaban Impurity 11 is a high-purity chemical reference standard used in the pharmaceutical development and quality control of the anticoagulant drug Rivaroxaban. This impurity is critical for ensuring the safety, efficacy, and regulatory compliance of the final drug product by enabling accurate identification and quantification of related substances. It is an essential material for analytical chemists and quality assurance professionals in pharmaceutical R&D, manufacturing, and contract testing laboratories focused on cardiovascular therapies.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of Rivaroxaban Impurity 11 in active pharmaceutical ingredient (API) and finished drug product batches.
• Method Development and Validation: Critical for developing and validating robust analytical methods, such as HPLC and UPLC, for impurity profiling in compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Stability Studies: Used to monitor the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) to establish drug shelf-life.
• Quality Control & Batch Release: Essential for routine quality control testing to ensure that impurity levels in commercial Rivaroxaban API and formulations remain within specified safety limits.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., CMC sections for FDA, EMA) by providing characterized impurity data.
• Process Chemistry Research: Aids in understanding and optimizing the Rivaroxaban synthesis pathway to minimize the formation of this impurity.

Basic Information

Product Name	Rivaroxaban Impurity 11
CAS No.	1411775-06-8
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 11; Rivaroxaban EP Impurity J; Rivaroxaban USP Impurity J; Rivaroxaban Process Impurity; Xarelto Impurity 11; (5S)-5-({[(5-Chlorothiophen-2-yl)carbonyl]amino}methyl)-3-[4-(3-oxomorpholin-4-yl)phenyl]-1,3-oxazolidin-2-one
EINECS	Contact for details

Quality Control

Our Rivaroxaban Impurity 11 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical characterization using techniques including HPLC, NMR, and MS to confirm identity and purity, aligning with pharmacopeial expectations for reference standards. A detailed Certificate of Analysis (COA) is provided with each shipment, containing batch-specific data for identity, assay, purity, and related substances. We support compliance with ICH, USP, and EP guidelines for impurity qualification.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity. 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)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.2%

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