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Analytical development

AmatsiSEPS offers a wide range of analytical tools and services to characterize pharmaceutical dosage forms, and assess the (long-term) chemical and physical stability of active pharmaceutical ingredients in drug products.

AmatsiSEPS has a high level of expertise in analytical method development, and physical/chemical characterization of liquid and solid drug formulations. Using state-of-the-art equipment, we provide innovative solutions to enable the analysis of biomolecules and small synthetic molecules of therapeutic interest.

The following analytical capabilities are available to support formulation development:

  • Stability studies
    • Forced degradation and photostability studies
    • Excipient compatibility studies
    • Accelerated stability studies
    • In-use stability studies
  • Chromatographic method development and analysis
    • Assay and purity indicating high-performance liquid chromatography (HPLC) methods (reversed-phase, HILIC, SEC,…)
    • Enantioselective HPLC methods
    • LC-MS
    • Volatile organic impurity and residual solvent analysis by (headspace) gas chromatography (GC)
  • Moisture determination
    • Karl Fischer titration
    • Loss-on-drying
  • Dissolution studies
  • Thermal analysis
    • Differential scanning calorimetry (DSC)
    • Modulated DSC (mDSC)
  • Spectroscopic analysis
    • Ultraviolet (UV) spectroscopy
    • Fourier-transform infrared spectroscopy (FT-IR)
    • X-ray diffraction spectroscopy (XRD)
  • Particle size distribution analysis
    • Sieve analysis
    • Laser diffraction
    • Scanning electron microsopy (SEM)
  • Zeta-potential measurement
  • Tensile tester
    • Bioadhesion testing
    • Syringeability
    • Mini-tablet hardness testing
  • In-process control
    • pH
    • Density
    • Hardness
    • Friability
    • Desintegration time