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Stability testing of pharmaceutical products

Four Climate Zones: Climate zone I, II, III, IV

EAPHARMICS BLOG
 
Climate Zone I
Temperate
Climate Zone II
Mediterranean, Subtropical
Climate Zone III
Hot, Dry
Climate Zone IV
Hot, Humid
 

Climate Zone
Calculated Data
Derived Data

Countries

Temp.*
oC

MKT**
oC

Humidity
% r.h

Temp.
oC

Humidity
% r.h

Climate Zone I

*Temperate*

Japan, UK, Northern Europe, Canada, Russia, United States
20
20
42
21
45

Storage Condition acc. to ICH Q1A: 25oC/60%

Climate Zone II

*Mediterranean, Subtropical*

Japan, United States, Southern Europe
21,6
22
52
25
60

Storage Condition acc. to ICH Q1F: 30oC/65% r.h

Climate Zone III

*Hot, Dry*

Iran, Iraq, Sudan
26,4
27,9
35
30
35

Climate Zone IV

*Hot, Humid*

Brazil, Ghana, Indonesia, Nicaragua, Phillipines
26,7
27,4
76
30
70

Temp* = Temperature, MKT** = Mean Kinetic Temperature