ICH STABILITY ZONES
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 |
FIND MORE AT…
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
