Description

Regorafenib-13C-D3 is a stable isotope-labeled analog of the multi-kinase inhibitor Regorafenib, specifically enriched with carbon-13 and deuterium. This compound is an essential internal standard for the precise quantification of Regorafenib in complex biological matrices using advanced analytical techniques like LC-MS/MS. It is primarily required by pharmaceutical R&D laboratories, contract research organizations (CROs), and bioanalytical facilities engaged in pharmacokinetic studies, drug metabolism research, and clinical trial support.

Application

• Bioanalytical Method Development and Validation: Serves as a critical internal standard for the accurate and reliable quantification of Regorafenib in plasma, serum, and tissue homogenates.
• Pharmacokinetic (PK) and Pharmacodynamic (PD) Studies: Enables precise tracking of drug concentration over time to understand absorption, distribution, metabolism, and excretion (ADME) profiles.
• Clinical Trial Monitoring: Used in the bioanalysis of samples from clinical trials to ensure data integrity and regulatory compliance for submissions to agencies like the FDA and EMA.
• Drug Metabolism Research: Facilitates the identification and quantification of Regorafenib metabolites in in vitro and in vivo studies.
• Quality Control in Pharmaceutical Manufacturing: Can be employed in analytical procedures to monitor the active pharmaceutical ingredient (API) during production and in final dosage forms.

Basic Information

Product Name	Regorafenib-13C-D3
CAS No.	2126178-55-8
Molecular Formula	C₂₁H₁₂D₃¹³CClF₄N₄O₃
Molecular Weight	~504.8 g/mol
Synonyms	4-[4-({[4-Chloro-3-(trifluoromethyl)phenyl]carbamoyl}amino)-3-fluorophenoxy]-N-methylpyridine-2-carboxamide-13C-D3; BAY 73-4506-13C-D3; Stivarga-13C-D3; Regorafenib (phenyl-13C6, 3,4,5-D3); Regorafenib Labeled Standard; Regorafenib Isotopic Label; Regorafenib Internal Standard; Regorafenib-d3-13C6
EINECS	Contact for details

Quality Control

Every batch of Regorafenib-13C-D3 is manufactured and analyzed under strict quality systems. We guarantee high chemical and isotopic purity, confirmed by advanced spectroscopic and chromatographic methods including NMR, HPLC, and MS. A comprehensive Certificate of Analysis (COA) detailing purity, isotopic enrichment, and analytical results is provided with each shipment to ensure traceability and compliance with your research or quality protocols.

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 material is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccants or inert atmosphere to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms to reference standard
Identification (MS)	Conforms to expected mass spectrum
Purity (HPLC)	≥ 98.0%
Isotopic Purity (¹³C)	≥ 99 atom % ¹³C
Isotopic Purity (D)	≥ 98 atom % D
Chemical Purity (NMR)	Conforms to structure
Water Content (KF)	≤ 0.5%
Residual Solvents (GC)	Meets ICH guidelines

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