Description

Sorafenib 13C D3 is a stable isotope-labeled analog of the multi-kinase inhibitor Sorafenib, specifically designed for use as an internal standard in quantitative bioanalytical studies. This high-purity compound is essential for ensuring the accuracy and reliability of pharmacokinetic and metabolism data, critical for drug development and regulatory submissions. It is primarily utilized by pharmaceutical R&D laboratories, contract research organizations (CROs), and analytical service providers engaged in LC-MS/MS method development and validation.

Application

• Quantitative Bioanalysis: Serves as an internal standard for the precise quantification of Sorafenib and its metabolites in biological matrices (plasma, serum, tissue) using LC-MS/MS.
• Drug Metabolism and Pharmacokinetics (DMPK): Critical for studies investigating absorption, distribution, metabolism, and excretion (ADME) profiles of Sorafenib.
• Clinical Research: Used in the analysis of patient samples during clinical trials to monitor drug exposure and compliance.
• Method Development & Validation: Enables the development of robust, sensitive, and specific analytical methods compliant with FDA, EMA, and ICH guidelines.
• Forensic Toxicology: Supports accurate measurement in cases of overdose or therapeutic drug monitoring.
• Reference Material: Acts as a certified reference material for calibrating analytical instruments and verifying method performance.

Basic Information

Product Name	Sorafenib 13C D3
CAS No.	1210608-86-8
Molecular Formula	C22H13D3 13C ClF3N4O3
Molecular Weight	~474.8 g/mol
Synonyms	Sorafenib-13C,d3; BAY 43-9006-13C D3; Nexavar-13C D3; 4-[4-[[[[4-Chloro-3-(trifluoromethyl)phenyl]amino]carbonyl]amino]phenoxy]-N-methyl-2-pyridinecarboxamide-13C D3; Sorafenib (phenyl-13C,d3); Sorafenib Isotopically Labeled Standard; Sorafenib Internal Standard
EINECS	Contact for details

Quality Control

Our Sorafenib 13C D3 is manufactured under strict quality control protocols to ensure the highest isotopic and chemical purity required for sensitive mass spectrometry applications. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) detailing isotopic enrichment, chemical purity, and identity confirmation. Our quality system is designed to meet the rigorous standards of pharmaceutical R&D and regulatory compliance.

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 storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (MS)	Conforms to structure
Purity (HPLC)	≥98.0%
Isotopic Purity (MS)	≥99 atom % 13C; ≥98 atom % D
Chemical Purity (HPLC)	≥95.0%
Water Content (KF)	≤1.0%
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.