Question:
As per ICH stability guidelines, Climatic Zone II (Subtropical/Mediterranean) is
As per ICH stability guidelines, Climatic Zone II (Subtropical/Mediterranean) is
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The world is divided into climatic zones for drug stability testing so that medicines are studied at storage conditions that match where they will actually be used.
Updated On: Jun 24, 2026
- 21°C / 45% RH
- 30°C / 35% RH
- 30°C / 65% RH
- 25°C / 60% RH
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The Correct Option is D
Solution and Explanation
Concept:
The world is divided into climatic zones for drug stability testing so that medicines are studied at storage conditions that match where they will actually be used. Each zone has a defined long-term storage temperature and relative humidity (RH) that products must be tested under.
Step 1: Recall the four zones. Zone I is temperate (21°C / 45% RH), Zone II is subtropical and Mediterranean (25°C / 60% RH), Zone III is hot and dry (30°C / 35% RH), and Zone IV is hot and humid (30°C / 65–75% RH).
Step 2: The question asks specifically about Zone II. Its long-term testing condition is 25°C and 60% RH, which is a moderate temperature with moderate humidity — fitting subtropical and Mediterranean regions.
Answer: Option (4) — Climatic Zone II corresponds to 25°C / 60% RH. (4)
The world is divided into climatic zones for drug stability testing so that medicines are studied at storage conditions that match where they will actually be used. Each zone has a defined long-term storage temperature and relative humidity (RH) that products must be tested under.
Step 1: Recall the four zones. Zone I is temperate (21°C / 45% RH), Zone II is subtropical and Mediterranean (25°C / 60% RH), Zone III is hot and dry (30°C / 35% RH), and Zone IV is hot and humid (30°C / 65–75% RH).
Step 2: The question asks specifically about Zone II. Its long-term testing condition is 25°C and 60% RH, which is a moderate temperature with moderate humidity — fitting subtropical and Mediterranean regions.
Answer: Option (4) — Climatic Zone II corresponds to 25°C / 60% RH. (4)
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