Description

Rivaroxaban Impurity 35 is a designated impurity standard used in the analytical profiling and quality control of the anticoagulant 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 an essential material for pharmaceutical R&D laboratories, quality assurance/quality control (QA/QC) units, and regulatory affairs teams involved in the development and manufacturing of Rivaroxaban.

Application

• Primary use as a certified reference standard (CRS) for the identification and quantification of Rivaroxaban Impurity 35 in API and finished dosage forms.
• Critical component in method development and validation for HPLC and UPLC analyses in pharmaceutical quality control laboratories.
• Used in stability studies to monitor the formation of degradation products under various stress conditions (e.g., heat, light, humidity).
• Essential for regulatory submissions (e.g., ANDA, NDA) to establish impurity profiles and meet ICH Q3A(R2) and Q3B(R2) guidelines.
• Serves as a research tool in pharmacokinetic and metabolic studies to understand the degradation pathways of Rivaroxaban.
• Supports process chemistry optimization by helping to identify and control impurities during the synthesis of Rivaroxaban.

Basic Information

Product Name	Rivaroxaban Impurity 35
CAS No.	2206360-74-7
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 35; Rivaroxaban EP Impurity G; Rivaroxaban Process Impurity; Rivaroxaban Degradant
EINECS	Contact for details

Quality Control

Every batch of Rivaroxaban Impurity 35 is manufactured and controlled under a strict quality management system. Our products undergo rigorous analytical testing, including advanced chromatographic and spectroscopic techniques, to ensure identity, purity, and consistency. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. Production adheres to relevant ICH guidelines, and the material is suitable for use in regulatory filing support.

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 desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unspecified impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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