Bioanalytical Chemistry Services

We provide bioanalytical services to support pre-clinical and clinical studies. Our experienced scientists offer a full range of LC/MS/MS bioanalytical services from methods development and methods validation to GLP sample analysis. We also perform metabolite identification and structure elucidation for impurity study. Our familiarity and compliance with regulatory requirements of the Food and Drug Administration and other agencies enable our clients to have complete confidence in the quality and acceptability of all analytical data.

Capabilities

  • LC/MS/MS and GC/MS method development and validation
  • Metabolite identification
  • Impurity characterization
  • Biological sample analysis (blood, urine, feces, aqueous humor, tissues, brain, plasma, serum) to support all phases of drug development
  • DMPK and toxicology support
  • Obesity biomarker platform (~180 analytes)
  • In-house synthesis of unavailable compounds (e.g., metabolites, internal standards)

Instrumentation

  • LC/MS/MS systems with ESI, APCI, APPI and nanospray ion sources
    • Sciex API 5000, 4000 (2), 3000 and 4000 QTrap (2) LC/MS/MS
    • Agilent 6410 LC/MS/MS
    • Waters Acquity TQD LC/MS/MS
    • Thermo Electron LTQ, LTQ ETD, and LCQ Deca LC/MSn
    • Hybrid and high-resolution MS
  • GC and GC/MS
  • UPLC and HPLC with PDA, UV, ELSD, RI, fluorescence and electrochemical detection
  • ICP-MS
  • CE with PDA

Additional Resources

  • Stable isotope and radiochemical synthesis
  • 500 and 300 MHz magnetic resonance spectrometers
  • AAALAC-accredited animal facility
  • Quality assurance
  • DEA Registrations Schedule I–V
  • Preclinical toxicology and DMPK testing under FDA guidelines
  • Toxicity testing under EPA and OECD guidelines