Description

Sorafenib Related Compound 10 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of pharmaceutical products by serving as a benchmark in impurity profiling and method validation. It is primarily needed by pharmaceutical manufacturers, analytical laboratories, and research institutions engaged in drug development and quality control for the oncology therapeutic area.

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, or LC-MS methods for stability-indicating assays.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing within pharmaceutical QC laboratories to monitor impurity levels against established specifications.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing characterized impurity data for drug master files (DMFs) and investigational new drug (IND) applications.
• Stability Studies: Used as a marker to track degradation pathways and establish the shelf-life of Sorafenib formulations under various stress conditions.
• Research & Development (R&D): Facilitates studies on the metabolism, pharmacokinetics, and toxicological profile of Sorafenib and its related substances.

Basic Information

Product Name	Sorafenib Related Compound 10
CAS No.	1012058-78-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Sorafenib Impurity 10; Sorafenib Related Substance 10; 4-(4-{3-[4-Chloro-3-(trifluoromethyl)phenyl]ureido}phenoxy)-N-methylpicolinamide N-Oxide; BAY 43-9006 Related Compound 10; Nexavar Impurity 10; Sorafenib N-Oxide (potential structure); Sorafenib Metabolite Reference Standard
EINECS	Contact for details

Quality Control

Every batch of Sorafenib Related Compound 10 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced chromatographic and spectroscopic techniques (e.g., HPLC, NMR, MS) to ensure compliance with pharmacopeial standards for reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). Due to its hygroscopic nature, the container should be kept in a desiccated environment to prevent moisture uptake. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual 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.