Description

Sorafenib Impurity 6 is a designated impurity of the active pharmaceutical ingredient Sorafenib, a multi-kinase inhibitor used in targeted cancer therapy. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development, stability studies, and quality control testing. It is essential for regulatory compliance, ensuring the safety and efficacy of the final drug product by monitoring and controlling impurity profiles. This high-purity standard is primarily utilized by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in oncology drug development and quality assurance.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Sorafenib Impurity 6 in drug substances and products.
• Analytical Method Development and Validation: Critical for developing, optimizing, and validating HPLC, UPLC, and LC-MS methods for impurity profiling.
• Stability Studies: Employed in forced degradation and long-term stability studies to monitor the formation of this specific degradation product.
• Quality Control & Batch Release: Acts as a system suitability standard and for setting specification limits in the quality control testing of Sorafenib API and finished dosage forms.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to establish impurity identification, qualification, and control strategies.
• Research and Development: Used in synthetic chemistry research to study the formation pathways and chemical behavior of this impurity.

Basic Information

Item	Detail
Product Name	Sorafenib Impurity 6
CAS No.	1285533-84-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Sorafenib Related Compound 6; Sorafenib Impurity F; 4-(4-{3-[4-Chloro-3-(trifluoromethyl)phenyl]ureido}phenoxy)-N-methylpicolinamide Impurity; BAY 43-9006 Impurity 6; Nexavar Impurity 6; Sorafenib Tosylate Impurity 6
EINECS	Contact for details

Quality Control

Our Sorafenib Impurity 6 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity analysis, spectroscopic identification (IR, NMR, MS), and residual solvent analysis, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) with detailed chromatographic data and structural confirmation is provided with every shipment to support your regulatory and quality needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or Certificate of Analysis. Keep the container in a dry, cool, and well-ventilated place. Handle and store in accordance with good laboratory practices.

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: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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