Analytical services

  • Preformulation studies
    • solubility, solid state form, particle properties, solid state and solution stability
  • Analytical methods development and Validation for API, excipients and drug products:
    • Dissolution
    • Assay
    • Content uniformity
    • Impurity
    • Karl-Fischer
  • 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
    • ICH-like stability conditions
    • Establishment of stress tests