Climatic Zones for Stability Studies

The climate is different in all the countries in the world. Stability studies of the pharmaceutical drug should be done according to the climatic conditions of the country. According to the ICH guidelines for stability studies, the climate of the 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 stability studies zones are created due to the difference in temperature and humidity in different parts of the world. These zones have different ICH stability conditions for pharmaceutical products. Following are ICH stability conditions for these zones.
Related: Significant Change in Pharmaceutical Stability Testing

Long Term Stability 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 Stability 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

Related: List of Current ICH Quality Guidelines
Update: The whole world is divided into 5 groups according to their climatic conditions. Following is the list of countries of different climatic zones for stability studies.

Classification of Countries According to Climate Zones
Country	Climatic Zones	Assigned To Zone
Afghanistan	I, II	II
Algeria	II, III	II
Angola	II, IV	II
Argentina	II	II
Armenia	I, II	II
Australia	I, II, III, IVa	II
Azerbaijan	I, II	II
Bahrain	IVa	IVa
Bangladesh	IVa	IVa
Barbados	IVb	IVb
Belize	IVa	IVa
Benin	IVa	IVa
Bolivia	I, II, IVb	IVb
Botswana	III	III
Brazil	II, IVb	IVb
Bulgaria	I, II	II
Burkina Faso	IVa	IVa
Burundi	IVa	IVa
Cameroon	IVb	IVb
Canada	I	I
Canary Islands	II	II
Central African  Republic	IVb	IVb
Chad	III, IVa	III
Chile	I, II	II
China	I, II, IVa	II
Columbia	IVb	IVb
Congo	II, IVa	IVa
Costa	IVa	IVa
Cuba	IVb	IVb
Dominican Republic	IVa	IVa
Dutch Antilles	IVa	IVa
Ecuador	I, II, IVa	IVa
Egypt	II, III	II
El Salvador	IVa	IVa
Ethiopia	II, IVa	IVa
Fiji	IVa	IVa
France	I, II	II
Gabon	IVa	IVa
Gambia	IVa	IVa
Georgia	I, II	II
Germany	I	I
Ghana	IVb	IVb
Greece	II, IVa	II
Guatemala	IVa	IVa
Guyana	IVb	IVb
Guinca	IVa	IVa
Haiti	IVa	IVa
Honduras	II, IVa	IVa
Hong Kong	IVa	IVa
India	III, IVb	IVb
Indonesia	IVb	IVb
Iran	I, II, IVa	II
Iraq	II, III, IVa	III
Israel	II, III	II
Italy	I, II	II
Ivory Coast	IVa	IVa
Jamaica	IVa	IVa
Japan	I, II, IVa	II
Jordan	II, III	III
Kampuchea	IVa	IVa
Kazakstan	I, II	II
Kenya	II, IVa	IVa
Kirghizia	I, II	II
Korea	I, II	II
Kuwait	IVa	IVa
Laos	IVb	IVb
Lebannon	II	II
Liberia	IVa	IVa
Libya	II, III	II
Madagascar	II, IVa	IVa
Malawi	II, IVa	IVa
Malaysia	II, IVb	IVb
Maldive Islands	IVa	IVa
Mali	III, IVa	IVa
Marshall Islands	IVa	IVa
Mauretania	IVa	IVa
Mexico	II, IVa	II
Morocco	II, III	II
Mozambique	IVb	IVb
Myanmar (Burma)	IVb	IVb
Namibia	II	II
Nepal	II	II
New Caledonia	II, IVa	IVa
New Zealand	I, II	II
Nicaragua	IVa	IVa
Niger	III, IVa	IVa
Nigeria	IVb	IVb
Oman	IVa	IVa
Pakistan	II, III, IVa	IVa
Panama	IVb	IVb
Papua-New Guinea	IVa	IVa
Paraguay	IVa	IVa
Peru	IVb	IVb
Philippines	IVb	IVb
Portugal	I, II	II
Puerto Rico	IVa	IVa
Qatar	IVa	IVa
Remaining Eastern European Nations	I	I
Remaining Northern and Central European Nations	I	I
Remaining Southern	II	II
European Nations
Rumania	I	I
Russia	I	I
Rwanda	II	II
Samoa	IVa	IVa
Saudi Arabia	II, III, IVa	IVa
Senegal	IVa	IVa
Sierra Leone	IVb	IVb
Singapore	IVb	IVb
Society Islands	IVa	IVa
Somalia	IVa	IVa
South Africa	II	II
Spain	I, II	II
Sri Lanka	IVa	IVa
Sudan	III, IV	IV
Syria	II	II
Tadzhikistan	I, II	II
Taiwan	IV	IV
Tanzania	II, IVb	IVb
Thailand	IVb	IVb
Togo	IVb	IVb
Tonga	II, IVa	IVa
Tunisia	II	II
Turkey	I, II	II
Turkmenia	I, II	II
Uganda	IVa	IVa
United Arab  Emirates	IVa	IVa
Uruguay	II	II
United States	I, II, III, IVa	II
Uzbekistan	I, II	II
Venezuela	II, IVb	IVb
Vietnam	IVb	IVb
Yemen	II, IVa	IVa
Zaire	II, IVa	IVa
Zambia	II	II
Zimbabwe	IVb	IVb

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