Stability study

For your pharmaceutical development or marketing monitoring projects.

Within the framework of our manufacturing operations, our teams of experts develop feasibility studies either in the context of quality monitoring or as part of a research and development project.

The SYNERLAB Group makes use of its storage and analysis capacity for your studies in compliance with the international standards EU-GMP/BPF and the corresponding ICH/EMEA guidelines.

Our analytical experts will support you in the definition of your study design before drafting your protocols (bracketing/matrixing).

STUDIES IN COMPLIANCE WITH THE STANDARDS IN FORCE

Our “stability study” department complies with all the conditions required for the completion of our tests. These studies are conducted within the framework of GMP and may concern a huge range of products intended for human and veterinary use as well as food supplements for:

  • active ingredients,
  • intermediate, bulk products,
  • finished pharmaceutical products,
  • medical devices.

OUR SKILLS

Our equipment allows us to store products under different long-term, intermediate and accelerated ICH conditions for climate zones I to IV as well as specific conditions upon request :

  • 25°C ± 2°C/60 % HR ± 5 %
  • 30°C ± 2°C/65 % HR ± 5 %
  • 30°C ± 2°C/75 % HR ± 5 %
  • 40°C ± 2°C/75 % HR ± 5 %
  • 2-8°C ; -20°C
  • Dry ovens ; 50°C/75 % HR
  • Suntest for photostability studies

The samples are stored in climate chambers and/or enclosures which are continually mapped and monitored in coordination with a 24 hour monitoring system.

Discover our equipment, which complies perfectly with the ICH and NFX standards in force.