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ICH STABILITY ZONES

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Four climatic zones can be distinguished for the purpose of worldwide stability as follows:

 

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 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

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Reference links

http://www.pharmatutor.org/articles/ich-guidlines-stability-data-review

http://www.google.co.in/url?url=http://vichsec.org/outreach-forum/index.php%3Foption%3Dcom_attachments%26view%3Dattachments%26task%3Dattachment%26id%3D1293&rct=j&frm=1&q=&esrc=s&sa=U&ved=0ahUKEwigrKHT4uvVAhVFrY8KHXyJC7o4ChAWCDkwBw&usg=AFQjCNHruP0KAD5lv1W2hjAfoS86VR2NxQ

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