Metabolite Characterization/Identification

Instrumentation

In vitro and in vivo studies frequently demonstrate differences in the characteristics of metabolite products by humans compared to other species. In particular, regulatory agencies frequently require detailed exploration into metabolites whose presence, or magnitude, is unique to humans prior to allowing clinical testing. XenoTech’s extensive selection of human and non-human microsomes and hepatocytes offers clients many choices of cellular systems for metabolite generation.

Our compound-driven high-resolution accurate mass spectrometry metabolite characterization studies provide extensive critical information about the metabolism of your compound in as little as 3 weeks. We routinely provide analyte-specific method development services, but can also employ your existing in-house analytical parameters for custom study design tailored to meet your needs.

Using state-of-the-art instrumentation and software, our experienced analytical scientists can perform thorough metabolic profiling across multiple species and comprehensive metabolite structural elucidation. Our SOPs meet or exceed FDA guidance document recommendations and we incorporate rigorous checks and controls to ensure confidence in the data we generate.

Knowledge of the rate at which your compound is biotransformed and the structure of any metabolites formed can help in the determination of a lead candidate and the development of a metabolically stable compound. This information is also useful in designing a structure to block a specific cleavage capable of yielding undesirable side effects. This service can augment reaction phenotyping studies or act as a stand-alone service for purposes of candidate qualification or safety studies.

Download XenoTech's Metabolite Characterization Informational Flyer Here!

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
  • MS^E Simultaneous acquisition of all precursor and product ion spectra in one injection for fast turnaround
• Waters Acquity UPLC™
• Waters MassLynx™ and MetaboLynx™ software packages to identify known and unexpected metabolites
• API 4000 QTRAP (linear ion trap) LC/MS/MS
  • Good sensitivity for detection of low-level metabolites
  • MS/MS/MS for confident structural elucidation
  • Analyst® and Light Sight® software data processing (control subtraction and isotope pattern filtering to identify known and unexpected metabolites
• UV, fluorescence and radiometric detection (LC/ARC dynamic flow and β-RAM) in conjunction with mass spectrometry

View a full list of XenoTech's analytical instrumentation here