Physicochemistry

Physicochemical Profiling

 

Parameter

Assays

pKa

  • Potentiometric titration (Sirius GLpKA)
  • Diode array detection D-PAS
  • Cosolvent system for hydrophobic substances

LogP (water / octanole)

  • Potentiometric titration (Sirius GLpKA)
  • Diode array detection D-PAS
  • Shake flask
  • Shake flask (miniaturized)

LogD (buffer / octanole)

  • Potentiometric titration (Sirius GLpKA)
  • Diode array detection D-PAS
  • Shake flask
  • Shake flask (miniaturized)

KIAM

  • Distribution coefficient between
    immobilized artificial membrane and a solution

Solubility in water

  • Nephelometric pH 7.4
  • Saturation solubility (shake flask)
  • Saturation solubility  (shake flask miniaturized)
  • BCS solubility

Stability in solution

  • At pH of solution
  • In a buffer system

Stability in physiological media

  • Gastrointestinal fluid (USP)
  • Chyle (USP)

Metabolic stability

  • Human liver microsomes
  • Microsomes of different animals (beagle, rat, mouse)

Protein binding

  • HSA binding (chromatographic)
  • Serum protein binding (ultrafiltration, human)
  • Serum protein binding (ultrafiltration, other  species)
  • Protein binding (ultrafiltration, single proteins)

Moisture

  • Loss on drying
  • Karl-Fischer titration

Characterisation

  • Purity
  • Assay

Factsheet "Physicochemical characterization"