cGMP Lab Capabilities

FreeThink’s comprehensive, state-of-the-art stability testing facilities feature the most current scientific advancements, and are DEA-compliant for controlled substances.  Call on our experienced scientists to manage your next cGMP stability study.

cGMP Stability Analyses

  • Accelerated stability
  • Analytical method transfer
  • Comparative stability
  • Drug product, drug-substance and OTC stability
  • ICH/Long-term stability services
  • In-use stability studies
  • Photostability
  • Stability-Indicating method validation

Sample Stability Chambers & Cabinets

We offer the following stability storage conditions:

  • 5°C (Refrigerated)
  • 25°C/60% RH (Climatic Zone II, Long-term Storage)
  • 30°C/65% RH (Climatic Zone IV, Long-term Storage)
  • 30°C/75% RH (Climatic Zone IVb, Long-term Storage)
  • 40°C/75% RH (Accelerated)
  • Photo-Stability, ICH Q1b (Option 2)

cGMP Qualified Analytical Instrumentation

  • Chromatography
    • HPLC
    • UPLC
  • Dissolution
  • Moisture
    • Karl Fischer
  • Photostability
    • ICH Options I and II