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Physicochemical Properties Analysis

Patheon offers the full breadth of advanced sciences to characterize the physicochemical properties of your drug substance to generate the data required to build a CMC package for your IND filing and lead the way to clinical trials. By maximizing the efficiency and flexibility of a non-GMP environment, and with all equipment in close proximity, we are able to quickly analyze and explore even small amounts of material to keep your project moving forward.

Characterization includes solubility – as a function of pH, temperature, solvents, stability – at IHC conditions for API, solutions and formulations, and identification of formulation options for in-vitro and preclinical in-vivo studies.

Drug Substance analysis

  • FTIR and appearance
  • Polarized and hot stage microscopy
  • TGA/DSC, pXRD and DMS

Preformulation assessment

  • Aqueous and solvent solubility
  • KF, pKa and logD
  • Solution and solid state stability

Analytical method development

  • Non-GMP
  • Stability indicating
  • Assay and degradants
  • Related substances

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