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Global community | Testing period (container type) | Storage condition (temperature/relative humidity, RH) |
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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 months | 30°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 |
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