Description

Regorafenib D3 is a deuterated isotopologue of the multi-kinase inhibitor Regorafenib, specifically labeled with three deuterium atoms. This stable isotope-labeled compound is essential for use as an internal standard in quantitative bioanalytical methods, ensuring the highest accuracy and reliability in pharmacokinetic and metabolism studies. It is a critical tool for pharmaceutical R&D laboratories, contract research organizations (CROs), and academic institutions engaged in advanced drug development and regulatory submission processes for oncology therapeutics.

Application

• Primary use as an Internal Standard in Liquid Chromatography-Mass Spectrometry (LC-MS/MS) for the quantification of Regorafenib in biological matrices.
• Supporting Drug Metabolism and Pharmacokinetics (DMPK) studies to understand absorption, distribution, metabolism, and excretion (ADME) profiles.
• Enabling high-precision Bioanalytical Method Development and Validation for clinical and preclinical trials.
• Use in Stable Isotope Dilution Assays to correct for matrix effects and instrument variability, improving data quality.
• Critical for Regulatory Compliance in analytical procedures supporting FDA, EMA, and other global health authority submissions.
• Research applications in Isotope Effect Studies to investigate the impact of deuterium substitution on metabolic pathways.

Basic Information

Product Name	Regorafenib D3
CAS No.	1255386-16-3
Molecular Formula	C₂₁H₁₂D₃ClF₄N₄O₃
Molecular Weight	483.85 g/mol (for monoisotopic mass)
Synonyms	4-[4-({[4-Chloro-3-(trifluoromethyl)phenyl]carbamoyl}amino)-3-fluorophenoxy]-N-methylpyridine-2-carboxamide-d3; BAY 73-4506 D3; Stivarga D3; Regorafenib (methyl-d3); Regorafenib-d3; Deuterated Regorafenib Internal Standard; [Methyl-d3]regorafenib
EINECS	Contact for details

Quality Control

Our Regorafenib D3 is manufactured under strict quality control protocols to ensure exceptional isotopic purity and chemical integrity, meeting the exacting requirements of analytical reference standards. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) detailing results for isotopic enrichment (e.g., D3 > 99%), chemical purity (by HPLC), and identity confirmation (by MS and NMR). We adhere to relevant industry guidelines for stable isotope-labeled compounds to guarantee reliable and reproducible performance in your critical assays.

Storage

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

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC-MS)	Conforms to reference standard
Identification (NMR)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Purity (D3)	≥ 99.0 atom % D
Water Content (KF)	≤ 0.5%
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.