Forced degradation studies

• Defining the degradation pathway of your drug substance & product.
• Assessing & validating the stability indicating power of your methods will require the subjection of your molecule to extreme stress conditions.
  Relevant stress conditions are:
  • Light
  • Heat (Temperature)
  • Humidity
  • Hydrolysis (acid/base)
  • Oxidation
  • Agitation
  • Freeze/Thaw cycling
  • Deamidation
• Target % of degradation will depend on your molecule & the method capabilities.

Meet our scientists

Our end-to-end analytical solutions for drug development

• Analytical Method and Lifecycle support

  • Assay & Method development
  • Method qualification
  • Method validation
  • Method transfer
  • Method lifecycle management
  • CMC consultancy
• Stability studies

  • ICH conditions
  • In-use stability
  • Forced degradation studies
  • Predictive stability studies
• Characterization studies

  • Developability
  • Product characterization
  • Process characterization/control
• Release testing

  • Non-GMP/GMP batches
  • Tox, PPQ and validation batches
  • Clinical and commercial batches