Description

Tegafur-13C,15N2 is a stable isotope-labeled analog of the chemotherapeutic prodrug Tegafur, specifically enriched with carbon-13 and nitrogen-15 isotopes. This compound is critically important for use as an internal standard in quantitative bioanalytical methods, ensuring the highest accuracy and reliability in pharmacokinetic and metabolic studies. It is an essential tool for pharmaceutical researchers, clinical laboratories, and contract research organizations (CROs) engaged in advanced drug development and regulatory compliance.

Application

• Primary use as an internal standard in Liquid Chromatography-Mass Spectrometry (LC-MS) and Gas Chromatography-Mass Spectrometry (GC-MS) for the quantification of Tegafur and its metabolites in biological matrices.
• Critical component in pharmacokinetic (PK) and bioequivalence studies to determine drug absorption, distribution, metabolism, and excretion (ADME) profiles.
• Enabling technology for metabolite identification and profiling in drug metabolism and pharmacodynamics (DMPK) research.
• Supporting clinical trial analysis and therapeutic drug monitoring (TDM) with enhanced precision and reduced matrix effects.
• Utilized in the development and validation of regulatory-compliant analytical methods for Good Laboratory Practice (GLP) and Good Clinical Practice (GCP) environments.
• Application in stable isotope dilution analysis (SIDA) for absolute quantification in complex samples.

Basic Information

Product Name	Tegafur-13C,15N2
CAS No.	1189456-27-6
Molecular Formula	C813C1H11N215N1O4
Molecular Weight	201.15 g/mol (labeled)
Synonyms	5-Fluoro-1-(tetrahydro-2-furanyl)-2,4(1H,3H)-pyrimidinedione-13C,15N2; FT-207-13C,15N2; Ftorafur-13C,15N2; 1-(Tetrahydro-2-furanyl)-5-fluorouracil-13C,15N2; Isotopically Labeled Tegafur; [13C,15N2]-Tegafur; Tegafur (13C,15N2)
EINECS	Contact for details

Quality Control

Our Tegafur-13C,15N2 is manufactured under controlled conditions to ensure exceptional isotopic and chemical purity, critical for trace-level analytical applications. Each batch undergoes rigorous quality testing, including comprehensive analysis by NMR, HPLC, and MS, to confirm isotopic enrichment, chemical identity, and purity. A detailed Certificate of Analysis (COA) is provided, documenting the isotopic purity (atom % 13C and 15N), chemical purity, and results of all specified tests to support your regulatory submissions and 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 or COA. Keep the container in a dry, well-ventilated place. For long-term storage, consider storing desiccated at -20°C.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Purity (13C)	≥ 99 atom %
Isotopic Purity (15N)	≥ 99 atom %
Chemical Purity (NMR)	Conforms
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.