Description

Sorafenib-D3 is a deuterated isotopologue of the multi-kinase inhibitor Sorafenib, 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 metabolic studies. It is a critical tool for pharmaceutical R&D laboratories, contract research organizations (CROs), and academic institutions engaged in advanced drug development and clinical research for oncology therapeutics.

Application

• Bioanalytical Internal Standard: Primary use as a certified reference material in Liquid Chromatography-Mass Spectrometry (LC-MS/MS) for the precise quantification of Sorafenib in biological matrices (plasma, serum, tissue).
• Drug Metabolism and Pharmacokinetics (DMPK): Enables accurate tracking of drug absorption, distribution, metabolism, and excretion (ADME) profiles in preclinical and clinical studies.
• Clinical Research: Supports therapeutic drug monitoring (TDM) and bioequivalence studies for Sorafenib-based cancer treatments.
• Pharmaceutical Quality Control: Used in method development and validation to ensure compliance with regulatory guidelines (FDA, EMA) for assay specificity and accuracy.
• Isotope Dilution Mass Spectrometry (IDMS): Serves as the ideal spike-in standard for high-precision quantification, minimizing matrix effects and instrumental variability.

Basic Information

Product Name	Sorafenib-D3
CAS No.	1130115-44-4
Molecular Formula	C21H13D3ClF3N4O3
Molecular Weight	464.85 g/mol (for C21H13D3ClF3N4O3)
Synonyms	BAY 43-9006-D3; Sorafenib (phenyl-d3); 4-(4-{3-[4-Chloro-3-(trifluoromethyl)phenyl]ureido}phenoxy)-N-methylpyridine-2-carboxamide-d3; Nexavar-D3 (deuterated); 4-[4-[[[4-Chloro-3-(trifluoromethyl)phenyl]amino]carbonyl]amino]phenoxy]-N-methyl-2-pyridinecarboxamide-d3; BAY 54-9085-D3; Sorafenib tosylate-D3 (deuterated analog)
EINECS	Contact for details

Quality Control

Our Sorafenib-D3 is manufactured under strict quality systems to ensure the highest isotopic and chemical purity required for sensitive analytical applications. Each batch is supported by a comprehensive Certificate of Analysis (COA) detailing results for identity, assay, isotopic enrichment, and purity by HPLC. We adhere to relevant industry standards for stable isotope-labeled compounds, and our quality commitment ensures data integrity for your regulatory submissions.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as specified on the certificate of analysis. The product is light-sensitive (store away from light).

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (MS)	Conforms to expected mass
Purity (HPLC)	≥ 98.0%
Isotopic Purity (D3)	≥ 99.0 atom % D
Chemical Purity	≥ 98.0%
Water Content (KF)	≤ 0.5%
Residual Solvents (GC)	Complies with ICH limits

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