An initial drug substance characterization (IDSC) report contains physical characterization and preformulation data for your IND filing. To help you identify obstacles to the development of your compound, we 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. We can also perform polymorph screening and form identification. Preformulation data include equilibrium solubility, pH solubility, partition coefficient, pKa determination and accelerated physical and chemical stability.

For your regulatory submission, we can collect all or part of the IDSC package and summarize the information in a scientifically and QA-reviewed report that provides all the necessary data.

Our capabilities include:

Structure Elucidation

Physical Characterization

Preformulation Data

  • Equilibrium solubility
  • pH solubility
  • pKa determination
  • Log P
  • Log D
  • Accelerated physical and chemical solid and solution stability

Contact our solid state services team at SSCI by clicking below