Description

Sorafenib Impurity 73 is a designated pharmaceutical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of the active pharmaceutical ingredient (API) Sorafenib, a kinase inhibitor medication. It serves as a key marker for identification and quantification during method development, stability studies, and regulatory compliance testing. Pharmaceutical manufacturers, analytical laboratories, and research institutions rely on this high-purity impurity standard to meet stringent pharmacopeial requirements.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference standard for the identification and quantification of specific impurities in Sorafenib API and finished drug products.
• Analytical Method Development and Validation: Essential for developing, optimizing, and validating chromatographic methods (e.g., HPLC, UPLC) to ensure accurate impurity detection.
• Stability Studies: Employed to monitor the formation and levels of this impurity under various stress conditions (heat, light, humidity) as part of drug stability testing.
• Quality Control (QC) and Quality Assurance (QA): Provides a benchmark for in-process control and release testing of Sorafenib batches to ensure they meet predefined purity specifications.
• Regulatory Compliance and Submissions: Supports regulatory filings (e.g., for FDA, EMA) by providing characterized impurity data required for drug master files (DMFs) and new drug applications (NDAs).
• Research and Development: Used in metabolic studies, degradation pathway elucidation, and synthesis process optimization for Sorafenib.

Basic Information

Product Name	Sorafenib Impurity 73
CAS No.	862875-16-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Sorafenib Related Compound 73; Sorafenib Impurity C; 4-(4-{3-[4-Chloro-3-(trifluoromethyl)phenyl]ureido}phenoxy)-N-methylpyridine-2-carboxamide Impurity; BAY 43-9006 Impurity 73; Nexavar Impurity 73; Sorafenib Tosylate Impurity 73; 1-(4-Chloro-3-(trifluoromethyl)phenyl)-3-(4-(2-(methylcarbamoyl)pyridin-4-yloxy)phenyl)urea Impurity
EINECS	Contact for details

Quality Control

Our Sorafenib Impurity 73 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity confirmation and structural characterization via spectroscopic methods (NMR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment to support your quality and regulatory needs.

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 product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation.

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)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 5.0%
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.