Four climatic zones can be distinguished for the purpose of worldwide stability as follows:
Zone | Type of Climate |
Zone I | Temperate zone |
Zone II | Mediterranean/subtropical zone |
Zone III | Hot dry zone |
Zone IVa | 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 |
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Reference links
http://www.pharmatutor.org/articles/ich-guidlines-stability-data-review