Climatic Zones For Stability Studies

Climatic zones ich

The drug products are tested under various environmental conditions to collect data regarding the stability of drug products.



Pharmaceutical drug products are stored under various ranges of temperature & humidity & are tested to check the safety & efficacy of that drug product after a specified period of time.

The temperature & humidity of all the countries is not the same. That is why the ICH has divided the whole world into various climatic zones.

Importance Of Climatic

Stability zones play an important role in collecting stability data of a drug product.

  • One must have to collect stability data of new drug products according to the climatic zone of the country where it is going to be registered.
  • For export of a drug product in a specific country we must collect stability data according to the zone of that country.
  • Storage conditions for various pharmaceutical drug products are determined by testing the product in various climatic conditions.

Climatic Zones For Stability Studies

The world is divided into four climatic zones & zone IV is further subdivided into two zones which are IVa & IVb so by adding by division we have 5 ICH climatic zones.

The numbering of climatic zones for stability studies is given below,

  • Zone I
  • Zone II
  • Zone III
  • Zone IVa 
  • Zone IVb




The names of above mentioned climatic zones are given below

Zone Zone Name/Climate 
Zone ITemperate
Zone IIMediterranean/

Subtropical 

Zone IIIHot Dry
Zone IVaHot Humid/Tropical 
Zone IVbHot Higher Humidity 

Following are the long-term stability study conditions for above mentioned ICH stability zones

Long-Term Stability Studies

 

Zone Temperature Humidity Duration 
Zone I21°C ± 2%45% RH ±5%12 Month
Zone II25 °C± 2%60% RH ±5%12 Month
Zone III30 °C± 2%35% RH ±5%12 Month
Zone IVa30 °C± 2%65% RH ±5%12 Month
Zone IVb30 °C± 2%75% RH ±5%12 Month

Countries According To Climatic Zones

Following is the division of main countries according to their climatic zones




Name Zone 
UK 

   Zone I

North Europe 
Germany 
Russia 
Canada 

 

Name Zone 
USA 

   Zone II

China 
Iran
Japan
Australia 

 

Name Zone 
Iraq  

  Zone III

Jordan 
Botswana 

 

NameZone 
Pakistan     

   Zone IV

India 
Bangladesh 
Omam
EUE
Indonesia 

Also Read

  1. Potency calculation of Active pharmaceutical Ingredient.
  2. Why Do We Use Three Batches For Validation
Share To Others

2 thoughts on “Climatic Zones For Stability Studies”

Leave a Comment

Your email address will not be published. Required fields are marked *