Stability Studies

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We provide full service of ICH and on-going stability programs for third parties. The services, at client's choice, can include: method transfer, method improvement, analytical standards management, storage at different conditions, scheduling of analytical timepoints, full analysis and out-of-trend (OOT) and out-of-specification (OOS) management. These tasks are always performed according to procedures agreed with the client.

Conditions available:

  • Standard conditions: 25ºC / 60%RH;  30ºC / 65%RH;  40ºC / 75%RH
  • Tropical condition (zone IVb): 30ºC / 75%RH
  • Semipermeable conditions: 25ºC / 40%RH; 40ºC / 25%RH
  • Refrigerated condition: 5ºC
  • Freezer condition: - 20ºC

If the analytical methods are not available, we can perform stress testing (light, pH, humidity, temperature and oxidation) and development and validation of stability indicating methods.

Other related services:

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  • Compatibilty studies of ingredients
  • Leachables and Extractable testing
  • Photostability
  • Holding time studies for bulk products
  • In use stability
  • Transport stability
  • On-going stability programs

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