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Stability studies 2016-10-31T08:31:29+00:00

STRESS/STABILITY STUDIES

The development of forced degradation and stability studies was a natural consequence of the existent service portfolio Roowin offers. Initially developed to satisfy the demand of our customers engaging in cGMP syntheses, we today offer stability studies as well as accelerated degradation studies as an independent service.

Without contrary instructions from our customers, we strictly follow ICH guidelines. We thus usually precede a stability study by an accelerated degradation, exposing samples to the following types of stress:

ICH guidelines:

  • Oxidative environment
  • Varying pH
  • Radicals
  • Varying temperatures & humidities
  • Photostress

This preliminary study allows us to specifically develop and optimize analytical methods capable of detecting traces of degradation impurities that will form during the subsequent stability study.

We currently work with Secasi and Binder climatic rooms. The stability studies currently run at Roowin comprise sterile and non-sterile compounds.

Our facility includes:

  • 8 stability chambers with full traceability
  • Stability condition: 40°C ± 2°C / 75% RH ± 5% RH
  • Stability condition: 30°C ± 2°C / 65% RH ± 5% RH
  • Stability condition: 20°C ± 2°C / 60% RH ± 5% RH
  • Stability condition: 5°C ± 3°C
  • Stability condition: -20°C ± 5°C
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