ICH stability zones with the temperature condition, must remember

 

Please find classification of zones with the temperature and humidity condition.

ICH Stability Zones

Zone	Type of Climate
Zone I	Temperate zone
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