Description

n-Desmethyl Regorafenib n-Oxide (M5 Metabolite) is a key active metabolite of the multi-kinase inhibitor Regorafenib. This compound is of significant value for pharmaceutical research and development, particularly in the study of drug metabolism, pharmacokinetics, and the pharmacological activity profile of the parent drug. It serves as a critical reference standard and analytical tool for scientists and quality control professionals in the pharmaceutical and biotechnology industries, enabling precise quantification and characterization in biological matrices.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the quantitative analysis of Regorafenib and its metabolites in drug development and bioanalytical studies.
• Metabolite Identification & Profiling: Essential for in vitro and in vivo metabolism studies to understand the biotransformation pathways of Regorafenib.
• Pharmacokinetic (PK) & Pharmacodynamic (PD) Research: Used to calibrate assays for measuring metabolite concentrations in plasma, serum, and other tissues to establish exposure-response relationships.
• Bioequivalence & Impurity Testing: Critical for method development and validation in quality control labs to monitor metabolite-related impurities in active pharmaceutical ingredient (API) and finished drug products.
• Preclinical & Clinical Trial Support: Provides a definitive standard for data accuracy in non-clinical and clinical studies, ensuring regulatory compliance for submissions to agencies like the FDA and EMA.

Basic Information

Product Name	n-Desmethyl Regorafenib n-Oxide (M5 Metabolite)
CAS No.	835621-12-0
Molecular Formula	C₂₀H₁₄ClF₄N₃O₄
Molecular Weight	471.79 g/mol
Synonyms	Regorafenib M5 Metabolite; Regorafenib N-Oxide Metabolite; BAY 73-4506 M5; 4-[4-({[4-Chloro-3-(trifluoromethyl)phenyl]carbamoyl}amino)-3-fluorophenoxy]-N-methylpyridine-2-carboxamide N-Oxide; N-Desmethyl Regorafenib N-Oxide; M5 Metabolite of Regorafenib; BAY-73-4506 Metabolite M5
EINECS	Contact for details

Quality Control

Our n-Desmethyl Regorafenib n-Oxide (M5 Metabolite) is manufactured and handled under strict quality management systems. Each batch is subjected to comprehensive analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis. We provide a comprehensive Certificate of Analysis (COA) with each shipment, detailing batch-specific results. Our quality commitment ensures the material meets the high standards required for pharmaceutical research and regulatory applications.

Storage

Preserve in a tightly closed container, protected from light. Store at -20°C or below in a dry, moisture-free environment. This compound is hygroscopic (moisture-sensitive). For long-term storage, consider desiccation. Allow the sealed vial to equilibrate to room temperature before opening to minimize moisture condensation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms to reference standard
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH guidelines

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