Description

Rivaroxaban Impurity H CAS NO 1807455-76-0 is a high-purity chemical reference standard specifically used in the pharmaceutical development and quality control of the anticoagulant drug Rivaroxaban. This compound is critical for ensuring drug safety and efficacy by enabling the accurate identification, quantification, and control of related substances during manufacturing. It is an essential material for analytical laboratories, regulatory affairs, and R&D departments within the global pharmaceutical and biotechnology sectors.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Rivaroxaban Impurity H in active pharmaceutical ingredient (API) and finished drug product analysis.
• Method Development and Validation: Critical for developing and validating robust analytical methods, such as HPLC and UPLC, to monitor impurities in compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control (QC) Testing: Used in routine QC testing in pharmaceutical manufacturing to ensure batch-to-batch consistency and that impurity levels remain within specified safety thresholds.
• Stability Studies: Employed as a marker in forced degradation and long-term stability studies to understand the degradation pathways of Rivaroxaban.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing necessary impurity characterization data for drug approval dossiers.
• Research and Development: Facilitates process chemistry research aimed at optimizing synthesis routes to minimize the formation of this specific impurity.

Basic Information

Product Name	Rivaroxaban Impurity H
CAS No.	1807455-76-0
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 H; Rivaroxaban Impurity 10; Rivaroxaban EP Impurity H; Rivaroxaban USP Impurity H; Xarelto Impurity H; 4-(4-{[(5S)-5-(Aminomethyl)-2-oxo-1,3-oxazolidin-3-yl]phenyl}morpholin-3-one Impurity
EINECS	Contact for details

Quality Control

Our Rivaroxaban Impurity H is manufactured under strict quality management systems. Each batch is subjected to comprehensive analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis, to ensure it meets the stringent requirements for pharmaceutical reference standards. Certificates of Analysis (COA) with detailed chromatographic data are provided and traceable to primary standards where applicable.

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 must be kept in a desiccated environment to maintain stability and purity. Handle under an inert atmosphere if prolonged exposure is anticipated during weighing.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Any individual impurity ≤ 0.5% Total impurities ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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