ICH Stability Zones
|
Zone |
Type of Climate |
|
Zone I |
|
|
Zone II |
Mediterranean/subtropical zone |
|
Zone III |
Hot dry zone |
|
Zone IV |
Hot humid/tropical zone |
|
Zone IVb |
ASEAN testing conditions hot/higher humidity |
Long Term Testing Conditions
|
Climatic Zone |
Temperature |
Humidity |
Minimum Duration |
|
Zone I |
21ºC ± 2ºC |
45% rH ± 5% rH |
12 Months |
|
Zone II |
25ºC ± 2ºC |
60% rH ± 5% rH |
12 Months |
|
Zone III |
30ºC ± 2ºC |
35% rH ± 5% rH |
12 Months |
|
Zone IV |
30ºC ± 2ºC |
65% rH ± 5% rH |
12 Months |
|
Zone IVb |
30ºC ± 2ºC |
75% rH ± 5% rH |
12 Months |
|
Refrigerated |
5ºC ± 3ºC |
No Humidity |
12 Months |
|
Frozen |
-15ºC ± 5ºC |
No Humidity |
12 Months |
Accelerated and Intermediate Testing Conditions
|
Climatic Zone |
Temperature |
Humidity |
Minimum Duration |
|
Accelerated Ambient |
40ºC ± 2ºC |
75% rH ± 5% rH |
6 Months |
|
Accelerated Refrigerated |
25ºC ± 2ºC |
60% rH ± 5% rH |
6 Months |
|
Accelerated Frozen |
5ºC ± 3ºC |
No Humidity |
6 Months |
|
Intermediate |
30ºC ± 2ºC |
65% rH ± 5% rH |
6 Months |