Description

Rivaroxaban Impurity 36 is a high-purity chemical reference standard used in the analytical profiling and quality control of the anticoagulant active pharmaceutical ingredient (API) Rivaroxaban. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure product safety, efficacy, and regulatory compliance by accurately identifying and quantifying process-related impurities. It is an essential tool for research and development, method validation, and stability studies within the pharmaceutical industry, particularly for those developing or producing generic versions of Rivaroxaban.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the qualitative and quantitative analysis of Rivaroxaban API and finished dosage forms.
• Method Development & Validation: Critical for developing and validating robust HPLC, UPLC, or LC-MS analytical methods to monitor impurity profiles.
• Quality Control (QC) & Quality Assurance (QA): Used in routine batch release testing to ensure Rivaroxaban products meet stringent pharmacopeial (e.g., USP, EP) and ICH guidelines for impurity limits.
• Stability Studies: Employed to identify and track the formation of degradation products in Rivaroxaban formulations under various stress conditions.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Process Chemistry Research: Aids in optimizing synthesis pathways by identifying and quantifying specific synthetic impurities.

Basic Information

Product Name	Rivaroxaban Impurity 36
CAS No.	1770812-39-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Rivaroxaban Related Compound 36; Rivaroxaban EP Impurity G; Rivaroxaban USP Impurity; 5-Chloro-N-({(5S)-2-oxo-3-[4-(3-oxomorpholin-4-yl)phenyl]-1,3-oxazolidin-5-yl}methyl)thiophene-2-carboxamide; UNII-9J8K4A9S6M; Rivaroxaban Impurity 36 (EP); Rivaroxaban Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Rivaroxaban Impurity 36 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling 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, and is available upon request.

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 (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.