Description

Sorafenib Related Compound B is a high-purity chemical reference standard critical for pharmaceutical research and development. This compound serves as a key impurity marker and analytical standard in the quality control of Sorafenib, a widely used multi-kinase inhibitor. It is essential for laboratories in the pharmaceutical and biotechnology sectors requiring precise analytical methods for drug substance characterization and regulatory compliance.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in Sorafenib active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Serves as a critical standard for developing, calibrating, and validating High-Performance Liquid Chromatography (HPLC) and other chromatographic methods.
• Quality Control & Assurance (QC/QA): Employed in routine quality control testing to ensure batch-to-batch consistency and compliance with pharmacopeial standards (e.g., USP, EP).
• Stability Studies: Acts as a marker compound in forced degradation and long-term stability studies to understand the degradation pathways of Sorafenib.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., with the FDA, EMA) to demonstrate thorough impurity control and the safety profile of the drug substance.
• Research & Development: Utilized in synthetic chemistry research for process optimization and impurity synthesis studies related to Sorafenib manufacturing.

Basic Information

Product Name	Sorafenib Related Compound B
CAS No.	2004659-84-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Sorafenib Impurity B; Sorafenib Related Substance B; 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 B; Sorafenib N-Oxide; Sorafenib EP Impurity B
EINECS	Contact for details

Quality Control

Our Sorafenib Related Compound B is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including chromatographic purity assays and structural confirmation, to ensure it meets the stringent requirements for pharmaceutical reference standards. Certificates of Analysis (COA) with detailed chromatographic data, including HPLC purity and related substance profiles, are provided for traceability and regulatory support.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity. Handle under an inert atmosphere if prolonged exposure is anticipated.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
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.