ICH Stability Zones/ Zone | Type of Climate | Limit (Mean Annual Temp. / Mean Annual water Vapour Pressure) | Testing conditions [ ◦C / % RH] |
Zone I | Temperate zone | ≤15°C/ ≤11hPa * | 21 / 45 |
Zone II | Mediterranean/subtropical zone | ˃ 15° to 22°C / ˃ 11 to 18 hPa | 25 / 60 |
Zone III | Hot dry zone | ˃ 22°C /≤15 hPa | 30 / 35 |
Zone IVa | Hot humid/tropical zone | ˃ 22°C / ˃ 15 to 27 hPa | 30◦C / 65% RH |
Zone IVb | Hot/higher humidity | ˃ 22°C / ˃ 27 hPa | 30◦C / 75% RH |
*≤hPa- Hectopascal
Long term conditions for stability data :
WHO and ICH guidelines Long term testing conditions (Temp. /Humidity) | Testing conditions | Climatic Zones | Long term Stability testing which could be realized in order to cover all climatic zones |
21°C/ 45% RH | Long term | Zone I | 25°C/ 60% RH |
25°C/ 60% RH | Long term | Zone I and II | 25°C/ 60% RH |
30°C/ 35% RH | Long term | Zone III | 30°C/ 65% RH |
30°C/ 65% RH | Intermediate Long term | Zone I and II Zone IV a | 30°C/ 65% RH |
30°C/ 75% RH | Long term | Zone IV b | 30°C/ 75% RH |
ICH storage conditions of stability studies
Region | Zone I and II countries | Zone III and IV countries |
Europe | All countries | NA |
America | Argentina, Bolivia, Chile, Canada, Mexico, Peru, Uruguay, USA | Barbados, Belize, Brazil, Costa Rica, Dominican Republic, Ecuador, El Salvador, Guatemala, Guyana, Haita, Honduras, Jamaica, Columbia, Cuba, Nicaragua, Dutch Antilles, Panama, Paraguay, Puerto Rico, Venezuela. These nations are all grouped under CZ IV. |
Asia | Afghanistan, Armenia, Azerbaijan, China, Georgia, Iran, Israel, Japan, Kazakstan, Kirghizia, Korea, Lebanon, Nepal, Syria, Tadzhikistan, Turkey, Turkmenia, Uzbekistan | Bahrain, Bangladesh, Hong Kong, India, Indonesia, Iraq(III), Jordan (III), Kampuchea, Qatar, Kuwait, Laos, Malaysia, Maldives Islands, Myanmar, Oman, Pakistan, Philippines, Saudi Arabia, Singapore, Sri Lanka, Taiwan, Thailand, United Arab Emirates, Vietnam, Yemen |
Africa | Egypt, Algeria, Tunesia, Libya, Morocco, Namibia, Ruanda, South Africa, Tunesia, Zambia, Zimbabwe. | Angola, Ethiopia, Benin, Botswana (III), Burkino Faso, Burundi, Djibouti, Ivory Coast, Gabon, Gambia, Ghana, Guinea, Cameroon, Kenya, Longo, Liberia, Madagascar, Malawi, Mali, Mauritania, Mozambique, Niger, Nigeria, Senegal, Sierra Leone, Somalia, Sudan, Tanzania, Togo, Chad (III), Uganda, Zaire, Central African Republic. |
Australian/ oceanic | Australia, New Zealand. | Figi Society Islands, Marshall Islands, New Caledonia, Papua-New Guinea, Samoa, Tonga. |
Realated: Q1A (R2) : Stability testing of new drug substances and products, Q2(R1): Validation of Analytical Procedures
Definition of MKT:
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