Metabolite Identification with HRMS
Metabolite Identification with HRMS Services
Our metabolite identification (MetID) team performs qualitative structure elucidation of metabolites and helps characterize biotransformation pathways. In conjunction with quantitative metabolite profiling, this data reveals any disproportionate human metabolites and inform if there are requirements to consider additional safety testing of metabolites and/or drug-drug interaction (DDI) studies.
Our mass spectrometry experts interpret the spectral data with accurate mass using their extensive experience in determining compounds structure. Analysis of fragment ion data helps elucidate and confirm the molecular structure of all metabolites of interest.
- HPLC/UPLC metabolite profiling methods are transferred and verified
- Profiling in AUC plasma or specific timepoint pools (per subject/across subjects)
- Profiling in urine and fecal homogenate excreta pools (per subject/across subjects)
- Profiling of metabolites can also be conducted in bile, CSF, specific tissue or cellular fractions (e.g. PBMCs)
Dedicated ADME Laboratories
- GLP/GCP accredited
- State-of-the-art high resolution and accurate mass instrumentation for metabolite identification (Thermo LTQ Orbitrap‑XL, Thermo Q-Exactive and Waters Q‑Tof Vion)
Performed in Accordance with FDA Regulatory Guidance
- FDA ‘Safety Testing of Drug Metabolites’ – Guidance for Industry (November 2016, March 2020)
- ‘Metabolites in Safety Testing’ (MIST) PhRMA Position Paper (April 2016)