Review Article

Global Comparison of Stability Testing Parameters and Testing Methods for Finished Herbal Products

Table 5

Storage conditions used for intermediate stability testing.

Global communityTesting period (container type)Storage condition (temperature/relative humidity, RH)

EEC [7]6 months (general container)30°C ± 2°C/65% RH ± 5% RH
6 months (semipermeable container)30°C ± 2°C/35% RH ± 5% RH
EMA [35]6 months (general container)30°C ± 2°C/65% RH ± 5% RH
6 months (semipermeable container)30°C ± 2°C/65% RH ± 5% RH
ICH [36]6 months (general container)30°C ± 2°C/65% RH ± 5% RH
6 months (semipermeable container)30°C ± 2°C/65% RH ± 5% RH
WHO [3]6 months (general case)30°C ± 2°C/65% RH ± 5% RH
6 months (semipermeable case)30°C ± 2°C/35% RH ± 5% RH
Australia [12]6 months (general container)30°C ± 2°C/65% RH ± 5% RH
6 months (semipermeable container)30°C ± 2°C/65% RH ± 5% RH
China [17, 18]0, 1, 2, 3, and 6 months30°C ± 2°C/65% RH ± 5% RH
Japan [24]6 months (general container)30°C ± 2°C/65% RH ± 5% RH
6 months (semipermeable container)30°C ± 2°C/65% RH ± 5% RH
Korea [27]More than 12 months (general container)30°C ± 2°C/65% RH ± 5% RH
More than 12 months (semipermeable container)30°C ± 2°C/35% RH ± 5% RH