Species Comparison and Metabolite Profiling

The metabolic stability and metabolite profile of the test item is investigated and compared with respect to different species in vitro. The data obtained provide valuable information for species selection in toxicological studies in vivo.

Study Outline

Quantity of test item required: 10 mg/species
Turnaround time of draft report: 20-30 working days

Study Design

• range finding
• triplicates
• one concentration of test system
• one concentration of test item
• one to six time points
• positive control: formation of 7-hydroxycoumarin and/or selected phase I and /or phase II marker reactions
• negative control: zero time point and/or no NADPH
• TI blank (no test item)
• TS blank (no test item)
• TITS blank (no test item, no test system
  
  

Analytics

• HPLC-DAD/FLD or LC-MS/MS or Radiodetection:
  loss of parent compound and /or formation of selected metabolites and/or identification of major phase I oxidative metabolites and/or major phase II conjugates by mass relative to the parent compound