Analytical and Bioanalytical Services

We use state-of-the-art instrumentation to support projects in medicinal chemistry, process development, drug formulation, preclinical and clinical drug development, and quality control of raw ingredients.

Our analytical services include:

  • chromatographic separation
  • quantitation of major and minor components in raw API and formulated drug products
  • identification of impurities generated during manufacturing, stress testing, and stability studies
  • analytical support for the design, synthesis, and scale-up of new chemical entities
  • development of qualitative and quantitative analytical methods in HPLC, LC/MS or LC-MS/MS for support of preclinical drug discovery studies
  • method qualification
  • acquisition, processing and reporting of preclinical and pharmacokinetic and toxicokinetic data, including ADME, protein binding and metabolites identification
  • development of qualitative and quantitative bio-analytical methods using LC-MS/MS (Applied Biosystems/MDS SCIEX API 4000 triple quadrupole mass spectrometer) for small molecules and metabolites in biological matrices (plasma, urine, and various tissues)
  • analytical support for pharmacokinetics studies, dose formulation and dose verification, metabolite identification, stability, solubility, and other experimental needs
  • development of small molecule extraction protocols for various biological matrices using liquid-liquid extraction (LLE), solid phase extraction (SPE) and protein precipitation techniques
  • PK data generation and interpretation for non-compartmental analysis using WinNonlin software
  • 96-well sample processing and analysis