Description

Sorafenib n-Oxide is a key metabolite and reference standard of the multi-kinase inhibitor Sorafenib. This compound is of significant importance for pharmaceutical research and development, particularly in the study of drug metabolism, pharmacokinetics, and bioanalytical method validation. It is primarily utilized by research institutions, pharmaceutical companies, and contract research organizations (CROs) engaged in oncology drug development and quality control processes.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the qualitative and quantitative analysis of Sorafenib and its metabolites in drug substances and products.
• Metabolite Identification & Profiling: Essential for in vitro and in vivo metabolism studies to understand the biotransformation pathways of Sorafenib.
• Bioanalytical Method Development: Serves as a critical standard for developing and validating HPLC, LC-MS, and LC-MS/MS methods in biological matrices.
• Pharmacokinetic (PK) Studies: Employed as an analytical standard to quantify metabolite levels in plasma, serum, and other tissues during PK/PD studies.
• Impurity Characterization: Used to identify, monitor, and control related substance impurities in Sorafenib active pharmaceutical ingredient (API) manufacturing.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing definitive characterization data for a major metabolite.

Basic Information

Product Name	Sorafenib n-Oxide
CAS No.	583840-03-3
Molecular Formula	C21H16ClF3N4O4
Molecular Weight	480.83 g/mol
Synonyms	Sorafenib N-Oxide; BAY 43-9006 N-Oxide; 4-[4-[[4-Chloro-3-(trifluoromethyl)phenyl]carbamoylamino]phenoxy]-N-methylpyridine-2-carboxamide 1-oxide; Nexavar Metabolite; Sorafenib Metabolite M-2; BAY 54-9085; 1-[[4-[4-[[[[4-Chloro-3-(trifluoromethyl)phenyl]amino]carbonyl]amino]phenoxy]pyridin-2-yl]carbonyl]-N-methyl-1λ⁴-pyridin-1-ium-1-olate
EINECS	Contact for details

Quality Control

Our Sorafenib n-Oxide is produced under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC purity assay, residual solvent analysis, and structural confirmation (NMR, MS) to ensure identity, potency, and consistency. A detailed Certificate of Analysis (COA) is provided with every shipment, documenting compliance with our stringent in-house specifications.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing desiccated at -20°C.

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)	Total impurities ≤ 2.0%
Water Content (KF)	≤ 0.5%
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.