Description

Sorafenib Related Compound 8 CAS NO 1431697-81-2 is a high-purity chemical reference standard, specifically designed for pharmaceutical research and development. This compound is critical for ensuring the quality, safety, and efficacy of the active pharmaceutical ingredient Sorafenib, a multi-kinase inhibitor. It is an essential tool for analytical chemists and quality control laboratories in the pharmaceutical and biotechnology sectors, primarily used for method development, validation, and impurity profiling.

Application

• Pharmaceutical Impurity Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of specific impurities in Sorafenib drug substance and finished products.
• Analytical Method Development & Validation: Serves as a critical component in developing and validating HPLC, UPLC, and LC-MS methods for impurity analysis.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to monitor and control impurity levels, ensuring compliance with ICH Q3A/B guidelines.
• Stability Studies: Used to track the formation of degradation products in Sorafenib formulations under various stress conditions.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research on Degradation Pathways: Aids in understanding the chemical stability and degradation mechanisms of Sorafenib.

Basic Information

Item	Details
Product Name	Sorafenib Related Compound 8
CAS No.	1431697-81-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Sorafenib Impurity 8; Sorafenib Related Substance 8; Sorafenib N-Oxide Impurity; 4-(4-{3-[4-Chloro-3-(trifluoromethyl)phenyl]ureido}phenoxy)-N-methylpyridine-2-carboxamide N-Oxide; BAY 43-9006 Related Compound 8; Nexavar Impurity 8; Sorafenib N-Oxide; Sorafenib Degradant
EINECS	Contact for details

Quality Control

Our Sorafenib Related Compound 8 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC purity determination, residual solvent analysis (GC), and structural confirmation (NMR, MS). We provide full traceability and a detailed Certificate of Analysis (COA) that includes batch number, expiration date, and results for all specified tests, ensuring compliance with ICH guidelines and customer-specific requirements.

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. For long-term storage, consider storing under inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Consistent with molecular structure
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unspecified impurity: ≤ 0.5% Total impurities: ≤ 2.0%
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.