Description

Rivaroxaban Impurity 12 is a designated impurity standard used in the analytical profiling and quality control of the 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 primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the development, production, and quality assurance of Rivaroxaban-based anticoagulant medications.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Rivaroxaban Impurity 12 in API and finished drug products.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating HPLC/UPLC methods to monitor impurities during the manufacturing process.
• Quality Control & Batch Release Testing: Employed in routine QC testing to ensure API batches comply with stringent pharmacopeial (e.g., USP, EP) and ICH Q3A/B guidelines for impurities.
• Stability Studies: Used to track the formation of this specific impurity over time under various stress conditions, supporting shelf-life determination.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research & Development: Aids in process chemistry research to understand and minimize the formation of this impurity during synthesis.

Basic Information

Item	Detail
Product Name	Rivaroxaban Impurity 12
CAS No.	936232-22-3
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 12; Rivaroxaban EP Impurity J; Rivaroxaban USP Impurity; Rivaroxaban Process Impurity; Xarelto Impurity 12; 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 12 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis. We provide full traceability with a detailed Certificate of Analysis (COA) that includes batch number, expiration date, and results against established specifications. Our standards support compliance with ICH, USP, and EP guidelines.

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. Avoid repeated or prolonged exposure to the 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)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C

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