Analytical services

  • Preformulation studies
    • solubility, solid state form, particle properties, solid state and solution stability
  • Analytical method development and validation for API, excipients and drug products:
    • Assay
    • Content uniformity
    • Related substances
    • Particle / droplet size
    • Viscosity
    • Karl-Fischer
    • Dissolution
  • Optimisation and validation of not well performing analytical methods
  • In Process Controls/ Physical characterization of dosage forms and API/ excipients
  • API-excipient compatibility studies
  • Stability testing
    • Real time and accelerated ICH conditions
    • Establishment of stress tests