The scope of analyses includes:

  • The analysis (stability) of raw materials and medicinal products or food storage tests
    • storage of the investigated samples (material, substance, product) in controlled temperature and humidity conditions in climate chambers, matching all climate zones
    • photostability tests
  • analyses of stored substance / product / packaging material at particular timepoints,
  • development and validation of test methods suitable in stability tests (e.g. stability indicating method),
  • assessment of the impact of formulation, manufacturing process, and packaging material on product stability,
  • expiry date assessment of raw material or  drug product.

Stability tests for pharmaceutical industry are carried out in accordance with recommendations of relevant ICH/EMA/FDA guidelines.