What is the accelerated storage condition for stability studies?

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SFDA: “Accelerated 40 °C ± 2 °C/ 75% RH ± 5% RH 6 months” (GCC v3.3 (archived) · 3.2.6.1 General case (FPP table)) “Accelerated 40 °C ± 2 °C/ 75% RH± 5% RH 6 months” (GCC v3.3 (archived) · 3.1.7.1 General case (API table)) EU: “Accelerated 40°C ± 2°C/75% RH ± 5% RH 6 months” (ICH Q1A(R2) · 2.2.7.1 General case (table)) “Accelerated 40° C ± 2° C/75% RH ± 5% RH 6 months” (EMA existing actives · 2.2.7.1 General case (table)) US FDA: “Accelerated 40°C ± 2°C/75% RH ± 5% RH 6 months” (FDA Q1A(R2) · 2.2.7.1 (table)) “Accelerated testing:  Studies designed to increase the rate of chemical degradation or physical change of a drug substance or drug product by using exaggerated storage conditions as part of the formal stability studies.” (FDA Q1A(R2) · 3 (Glossary)) WHO: “Accelerated 40 °C ± 2 °C/75% RH ± 5% RH 6 months” (WHO TRS 1010 Annex 10 · 2.2.7.1 General case (table))

What is the accelerated storage condition for stability studies?

SFDA Saudi Food and Drug Authority

EU European Union

US FDA US Food and Drug Administration

WHO World Health Organization

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