Stability Studies

Know different climatic zones by ICH in the world for stability conditions including Temperate, Mediterranean / subtropical, Hot dry, Hot humid / tropical and hot & higher humidity zones.

The climate is different in all the countries in the world. Stability study of the pharmaceutical drug should be done according to the climatic conditions of the country. According to the climate, world is divided into five different zones.

ICH Stability Zones
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:- Hot/higher humidity

These zones are created due to difference in temperature and humidity. Following are the climatic conditions for these zones.

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:- IVa, 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.