Description

n-Desmethyl Regorafenib is a key pharmacologically active metabolite of the multi-kinase inhibitor Regorafenib, representing a critical intermediate and reference standard in pharmaceutical development and quality control. Its significance lies in enabling precise pharmacokinetic studies, metabolic pathway elucidation, and the validation of analytical methods for the parent drug. This compound is essential for pharmaceutical R&D laboratories, contract research organizations (CROs), and quality assurance departments involved in the development, manufacturing, and regulatory submission of oncology therapeutics.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the quantification of Regorafenib and its metabolites in biological matrices during clinical and non-clinical studies.
• Metabolite Identification & Profiling: Critical for studying the biotransformation pathways of Regorafenib in vitro and in vivo to understand its efficacy and safety profile.
• Analytical Method Development & Validation: Serves as a primary standard for calibrating HPLC, LC-MS, and LC-MS/MS systems to ensure accurate assay and impurity testing of drug substances and products.
• Pharmacokinetic/Pharmacodynamic (PK/PD) Research: Enables the detailed investigation of exposure-response relationships for Regorafenib's active metabolites.
• Impurity Characterization: Employed to identify, qualify, and control process-related and degradation impurities in Regorafenib active pharmaceutical ingredient (API) batches.
• Regulatory Compliance & Submission: Supports regulatory filings (e.g., for FDA, EMA) by providing definitive characterization data for a major human metabolite.

Basic Information

Product Name	n-Desmethyl Regorafenib
CAS No.	1343498-72-5
Molecular Formula	C₂₀H₁₄ClF₄N₅O₃
Molecular Weight	483.80 g/mol
Synonyms	Regorafenib N-Desmethyl Metabolite; Regorafenib Metabolite M-2; BAY 73-4506 N-Desmethyl; 4-[4-({[4-Chloro-3-(trifluoromethyl)phenyl]carbamoyl}amino)-3-fluorophenoxy]-N-methylpyridine-2-carboxamide; N-Desmethyl BAY 73-4506; M2 Metabolite of Regorafenib; N-Demethyl Regorafenib
EINECS	Contact for details

Quality Control

Our n-Desmethyl Regorafenib is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity, LC-MS for identity confirmation, and residual solvent analysis, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing identity, purity (typically ≥95% to ≥98% by HPLC), and impurity profile is provided with every shipment to support your regulatory and research needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. This compound is hygroscopic (moisture-sensitive); the container must be kept tightly sealed in a dry environment to maintain stability and purity. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (Mass Spectrometry)	Consistent with molecular structure
Purity (HPLC)	≥95.0%
Related Substances (HPLC)	Individual impurity: ≤1.0% Total impurities: ≤3.0%
Water Content (KF)	≤1.0%
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.