Initial Drug Substance Characterization

Initial Drug Substance Characterization 2018-05-04T05:40:14+00:00

An Initial Drug Substance Characterization (IDSC) report contains physical characterization and preformulation data for your IND filing. SSCI will collect, analyze and summarize all data necessary for your regulatory documentation needs. Physical characterization data include form identification, solvent identification, hygroscopicity, micromeritics, and structure elucidation. Polymorph screening and form identification are also available. Preformulation data include equilibrium solubility, pH solubility, partition coefficient, pKa determination, and accelerated physical and chemical stability. SSCI can collect all or part of the IDSC package, and the information will be summarized in a scientifically and QA reviewed report that will provide all the data necessary for your regulatory submission.

Structure Elucidation

  • nuclear magnetic resonance (NMR)
  • solution NMR spectroscopy
  • IR spectroscopy
  • single crystal structure determination
  • mass spectrometry

Physical Characterization

  • x-ray powder diffraction (XRPD)
  • optical microscopy
  • differential scanning calorimetry (DSC)
  • thermogravimetry (TG)
  • melting point determination
  • moisture sorption/desorption isotherms
  • infrared (IR) spectroscopy
  • Raman spectroscopy
  • solid-state NMR spectroscopy
  • ultraviolet (UV)spectrum
  • particle size distribution
  • surface area
  • scanning electron microscopy

Preformulation Data

  • equilibrium solubility
  • pH solubility
  • pKa determination
  • Log P
  • Log D
  • accelerated physical and chemical solid and solution stability