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, 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 zones are created due to the difference in temperature and humidity. Following are the climatic conditions for these zones.
Related: Significant Change in Pharmaceutical Stability Testing
Related: Significant Change in Pharmaceutical Stability Testing
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
|
Related: List of Current ICH Quality Guidelines
Update: Following is the list of countries of different climatic zones.
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
|
The above data given basic clarity, Thank you sir.
ReplyDeleteThanking sir
ReplyDeleteWhat are the references for this data??
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