Stability Conditions for WHO Member States by Region-2021
- 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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