Question:
According to the ICH guidelines for stability studies, Climatic Zone II temperature and relative humidity are respectively:
According to the ICH guidelines for stability studies, Climatic Zone II temperature and relative humidity are respectively:
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Zone II is applicable to Europe, Japan, and parts of India — important for multinational drug stability protocols.
Updated On: Jul 14, 2026
- $ 25^\circ C $ and RH $ 60\% $
- $ 30^\circ C $ and RH $ 65\% $
- $ 40^\circ C $ and RH $ 75\% $
- $ 25^\circ C $ and RH $ 75\% $
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The Correct Option is A
Approach Solution - 1
- As per ICH (International Council for Harmonisation) guidelines:
- Climatic Zone II (Subtropical and Mediterranean) conditions:
$$
25^\circ C \pm 2^\circ C \text{ and } 60\% \pm 5\% \text{ RH}
$$
- These are standard long-term storage conditions for pharmaceutical stability studies.
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Approach Solution -2
This question asks for the storage temperature and relative humidity that define ICH Climatic Zone II, the long-term stability testing condition. Let's check each option against the zone definitions used in stability testing.
- \(25^{\circ}C\) and RH \(60\%\): This pair is the long-term storage condition assigned to Climatic Zone II, the Mediterranean and subtropical zone, which includes regions such as most of Southern Europe. It is the standard condition used for long-term stability studies of drugs intended for markets in this zone.
- \(30^{\circ}C\) and RH \(65\%\): This pair is used for Climatic Zone IVA, the hot and humid zone that includes much of India, Southeast Asia, and Central America, not Zone II.
- \(40^{\circ}C\) and RH \(75\%\): This pair is not a long-term storage condition at all. It is the accelerated stability testing condition applied on top of any zone to predict shelf life faster, typically run for six months.
- \(25^{\circ}C\) and RH \(75\%\): This combination pairs the Zone II temperature with a humidity value that belongs to Zone IVB, the hot and higher humidity zone, so it does not correspond to any single defined climatic zone.
Only the pairing of \(25^{\circ}C\) with \(60\%\) relative humidity matches the long-term storage condition defined for Climatic Zone II.
Therefore, the correct answer is \(25^{\circ}C\) and RH \(60\%\).
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