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Climatic Zones for Stability Studies


Know different climatic zones for stability studies 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

Update: Following is the list of countries of different climatic zones.

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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