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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

 

 

Fact Sheet

FCT03-I-0305_PC.pdf