Metabolite ID & Characterization

Overview

The 2008 FDA CDER Guidance for Industry, Safety Testing of Drug Metabolites (MIST) highlighted the need to consider the contribution of metabolites to overall toxicity as early as possible in the drug development process, as metabolites can be pharmacologically active and/or chemically reactive. In vitro metabolite characterization is an early step toward meeting the agency's need by enabling:
 
  • determination of human specific metabolites
  • detection of metabolites present in humans at disproportionally higher levels compared to toxicity model

Sekisui XenoTech’s extensive selection of products offers clients many choices of cellular systems for metabolite characterization. Sekisui XenoTech's metabolite characterization service can augment metabolic stability, drug inhibition and reaction phenotyping studies or act as a stand-alone service for purposes of designing appropriate toxicology studies.

Our compound-driven high-resolution accurate mass spectrometry metabolite characterization services provide extensive critical information about the metabolism of your compound in as little as 2 weeks. We routinely provide analyte-specific method development services for a custom study tailored to meet your needs, but can also employ your existing in-house analytical parameters.

Using state-of-the-art instrumentation and software, our experienced analytical scientists can perform thorough metabolic profiling across multiple species with comprehensive metabolite structural elucidation. We incorporate rigorous checks and controls to ensure confidence in the data we generate.
 

Metabolite Characterization Capabilities


Instrumentation

  • Waters Synapt™ G2 high-definition mass spectrometry system
    • Ion mobility spectrometry (IMS) for enhanced separation
    • Accurate mass for confident biotransformation assignment and structural elucidation of metabolites
    • MSE Simultaneous acquisition of all precursor and product ion spectra in one injection for fast turnaround
  • Waters Acquity UPLC™
  • Waters MassLynx™ and MetaboLynx™ software to identify known and unexpected  metabolites
  • Xevo G2-XS Tof/QTof
  • API 4000 QTRAP (triple quadrupole linear ion trap) LC/MS/MS
    • Sensitivity for detection of low-level metabolites
    • MS/MS/MS for confident structural elucidation
    • Analyst® and Light Sight® software to identify known and unexpected metabolites
  • UV, fluorescence and radiometric detection in conjunction with mass spectrometry

View a full list of Sekisui XenoTech's analytical instrumentation here
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<< Drug Metabolism
Metabolic Stability
Plasma Protein & Covalent Binding
CYP and UGT Reaction Phenotyping
Species Comparison
Non-CYP Metabolism


 

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