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Stability Conditions for WHO Member States by Region-2021

  • Writer: Jeremy Jakob
    Jeremy Jakob
  • Jan 30, 2023
  • 1 min read

Updated: Apr 4, 2023

Stability testing of Active Substances and Finished Drug Products



Stability conditions for WHO Member States by Region

The enclosed report is presenting the Stability Conditions required by a given Member State.

The main observation is that we can distinguish three main categories (with some exceptions).

  • +25°C/60% RH

  • +30°C/65% RH

  • +30°C/75% RH



A comprehensive approach would be to develop a stability program targeting the most relevant markets and focusing on +25°C/60% RH and +30°C/75% RH conditions. Justification as why +30°C/65% RH is omitted and that stability data generated at different conditions are predictable for behavior in other intermediate conditions.







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