Microbiological, Analytical, Chemistry & Nutritional Testing Laboratory

ICH Stability Zones

Zone

Type of Climate

Zone I

Temperate zone

Zone II

Mediterranean/subtropical zone

Zone III

Hot dry zone

Zone IV

Hot humid/tropical zone

Zone IVb

ASEAN testing conditions hot/higher humidity

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 IV

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