Description

Rivaroxaban Impurity 87 is a high-purity chemical reference standard used in the analytical profiling of the anticoagulant active pharmaceutical ingredient (API), Rivaroxaban. This compound is critical for pharmaceutical quality control and regulatory compliance, enabling the accurate identification and quantification of process-related impurities. It is primarily required by analytical laboratories, research institutions, and pharmaceutical manufacturers engaged in method development, stability studies, and batch release testing to ensure drug safety and efficacy.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the calibration of analytical instruments (HPLC, LC-MS) in Rivaroxaban API and finished product testing.
• Method Development and Validation: Used to develop, optimize, and validate chromatographic methods for impurity profiling in compliance with ICH Q2(R1) and Q3B(R2) guidelines.
• Stability Indicating Studies: Employed in forced degradation and long-term stability studies to monitor the formation of this specific impurity over time and under various stress conditions.
• Quality Control & Batch Release: Essential for setting specification limits and conducting routine quality control testing of Rivaroxaban drug substances and products.
• Regulatory Submissions: Provides necessary data and reference materials for regulatory filings (e.g., ANDA, NDA) with agencies like the US FDA and EMA.
• Research and Development: Used in synthetic chemistry research to understand impurity formation pathways and to develop purification processes.

Basic Information

Product Name	Rivaroxaban Impurity 87
CAS No.	482305-98-6
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 87; Rivaroxaban EP Impurity I; Rivaroxaban USP Impurity; Xarelto Impurity 87; 4-(4-{[(5S)-5-(Aminomethyl)-2-oxo-1,3-oxazolidin-3-yl]phenyl}morpholin-3-one 5-Chlorothiophene-2-carboxamide Derivative
EINECS	Contact for details

Quality Control

Every batch of Rivaroxaban Impurity 87 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced techniques like HPLC, LC-MS, and NMR to ensure compliance with pharmacopeial standards (USP, EP). A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, chromatograms, and traceability information.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F), in a dry environment. For long-term storage, consider storing desiccated at 2-8°C. Handle the material in accordance with good laboratory practices.

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)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0% w/w

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