Stability Studies According to ICH Standards

Etudes de stabilité selon les normes de l’ICH-GENERIKA

Our laboratory carries out stability studies in accordance with ICH guidelines. These studies can cover a wide range of products: samples of active ingredients, intermediates and finished products.

 

  • Accelerated and real-time stability tests
  • Storage conditions:
    • Long term, : 30°C ± 2°C, 65% HR ± 5%
    • Accelerated:  40°C ± 2°C, 75% HR ± 5%

 

  • Devising a stability protocol with monitoring of the following parametres:
    • Organoleptic characteristics (appearance, taste …)
    • Pharmacotechnical Control (dissolution, disintegration …)
    • Determination of active ingredients, preservatives, degradation products and antioxidants
    • Content-containing Interaction