BioPharma Services >> QC Services >> Stability Studies

Stability Studies

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Eurofins Pharma Services are equipped with temperature and humidity-controlled chambers and undergo stringent IQ, OQ, PQ and calibration processes

Industry leading service in product stability testing

The facilities at Eurofins Pharma Services are equipped with temperature and humidity-controlled chambers (under ICH conditions) and undergo stringent IQ, OQ, PQ and calibration processes on regular basis. All storage chambers are monitored 24h/7d with alert systems.

For your safety, we operate back up chambers for complete sample retrieval. In addition numerous thermostats, refrigerators, and freezers make it possible to do stability studies following regulations that govern the marketing of each type of product (ICH, ISO, CIPAC, …). Due to the amplitude of our testing capacity which is industry leading, we can offer you the flexible service and short turn around times in combination with our scientific and regulatory expertise.

Our services include:

  • Consultancy on the design of studies under both accelerated and shelf-life conditions
  • Development and validation of methods for products' critical parameters including all climatic zones (I - IV according to ICH) and long-term, intermediate and accelerated storage
  • Customer specific conditions
  • Analytical control of critical stability parameters
  • Analytical research for the identification of unknown degradation products
  • Storage and management of the stability samples
  • Preparation of preliminary reports for each period of stability

Available conditions

Cold storage

  • -80°C
  • -20°C
  • 5°C

Climate chambers

  • 25°C/40%RH
  • 25°C/60%RH
  • 30°C/35%RH
  • 30°C/65%RH
  • 30°C/75%RH
  • 40°C/<25%RH
  • 40°C/75%RH

Luminiscense chamber for photo stability studies