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Stability Storage Management

We offer comprehensive and cost effective stability management services for pharmaceuticals and biopharmaceuticals carried out according to cGMP and in line with recommended ICH guidelines.

Stability testing provides essential data on the quality of your product over time under the influence of environmental factors such as light, temperature and humidity which enables you to establish recommended storage conditions, shelf life and re-testing regimes. We work with you as a partner to offer a quality service that meets your needs.

Our stability cabinets are available for all standard ICH conditions and are automatically monitored. ICH stability services include long term stability, accelerated stability, comparative stability, forced degradation studies and photo stability. We are experts in protocol preparation, development of stability indicating methods and method validation.

Storage stability conditions

  • 25°C/60% RH
  • 30°C/65% RH
  • 40°C/75% RH
  • 25°C/40% RH
  • Zone IV 30°C/75% RH
  • 5°C and -20°C
  • -80°C ULT Freezer

 

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