Description

Rivaroxaban Impurity 14 is a high-purity chemical reference standard used in the pharmaceutical development and quality control of the anticoagulant drug Rivaroxaban. This impurity is critical for ensuring the safety, efficacy, and regulatory compliance of the final drug product by enabling accurate identification and quantification during analytical testing. It is an essential material for pharmaceutical R&D laboratories, quality assurance/quality control (QA/QC) units, and contract research organizations (CROs) focused on API synthesis and impurity profiling.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of Rivaroxaban Impurity 14 in active pharmaceutical ingredient (API) batches.
• Method Development and Validation: Crucial for developing and validating robust analytical methods, such as HPLC and UPLC, for impurity detection in Rivaroxaban.
• Quality Control & Stability Studies: Used in routine QC testing and forced degradation studies to monitor impurity levels and ensure product stability and shelf-life.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing characterized impurity data for drug master files (DMFs) and investigational new drug (IND) applications.
• Process Chemistry Research: Aids chemists in understanding and optimizing the Rivaroxaban synthesis pathway to minimize the formation of this specific impurity.

Basic Information

Product Name	Rivaroxaban Impurity 14
CAS No.	1429334-02-0
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 14; Rivaroxaban EP Impurity I; Rivaroxaban USP Impurity; Rivaroxaban Process Impurity; Xarelto Impurity 14
EINECS	Contact for details

Quality Control

Every batch of Rivaroxaban Impurity 14 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing, including advanced chromatographic and spectroscopic techniques, to ensure compliance with pharmacopeial standards and customer specifications. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing purity, identity, and impurity profile.

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 compound is hygroscopic (moisture-sensitive); therefore, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

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%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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