Description

Sorafenib β-D-Glucuronide is a key metabolite and reference standard of the multi-kinase inhibitor Sorafenib. This compound is critical for pharmaceutical research and development, particularly in the study of drug metabolism, pharmacokinetics, and bioanalytical method validation. It is primarily utilized by research institutions, contract research organizations (CROs), and pharmaceutical companies engaged in oncology drug development and regulatory submissions.

Application

• Metabolite Identification & Pharmacokinetic Studies: Used as an analytical reference standard to identify and quantify Sorafenib glucuronide metabolites in biological matrices (plasma, urine) during ADME studies.
• Bioanalytical Method Development & Validation: Serves as a critical calibrator and quality control sample in HPLC-MS/MS methods to ensure accurate and reproducible quantification of the metabolite.
• Drug Impurity Profiling: Employed as a known impurity or degradation product standard to monitor the stability and purity of Sorafenib active pharmaceutical ingredient (API) and finished dosage forms.
• In-vitro Metabolism Studies: Used in hepatocyte or microsomal incubation experiments to understand the glucuronidation pathway and enzyme kinetics of Sorafenib.
• Regulatory Compliance & Documentation: Essential for preparing regulatory filings (e.g., for FDA, EMA) by providing definitive characterization data for a major human metabolite.

Basic Information

Product Name	Sorafenib β-D-Glucuronide
CAS No.	1130164-93-0
Molecular Formula	C30H33ClF3N4O10
Molecular Weight	681.05 g/mol
Synonyms	Sorafenib Glucuronide; Sorafenib N-Oxide β-D-Glucuronide; BAY 43-9006 Glucuronide; 4-[4-[[[[4-Chloro-3-(trifluoromethyl)phenyl]amino]carbonyl]amino]phenoxy]-N-methyl-2-pyridinecarboxamide 1-β-D-Glucopyranuronic Acid; Nexavar Metabolite; Sorafenib N-Oxide Glucuronide Conjugate
EINECS	Contact for details

Quality Control

Our Sorafenib β-D-Glucuronide is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC purity analysis, LC-MS identification, and NMR confirmation to ensure structural integrity and high chemical purity suitable for research and analytical applications. Certificates of Analysis (COA) with detailed chromatographic data are available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store at -20°C or below in a dry, moisture-free environment. This hygroscopic and light-sensitive compound should be allowed to equilibrate to room temperature in a desiccator before opening to minimize moisture uptake.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC-MS)	Conforms
Identification (NMR)	Conforms
Purity (HPLC)	≥95.0%
Water Content (KF)	≤5.0%
Residual Solvents (GC)	Meets ICH guidelines

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