Question

As per ICH stability guidelines, Climatic Zone II (Subtropical/Mediterranean) is

• A. 21°C / 45% RH
• B. 30°C / 35% RH
• C. 30°C / 65% RH
• D. 25°C / 60% RH

Hint:

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.

Answer 1

The Correct Option is D

Step 1: Know the ICH climatic zones.
ICH Q1F defines four climatic zones for global stability studies. Each zone has a specific temperature and relative humidity (RH) condition.

Step 2: Recall Zone II specifically.
Zone I = Temperate (21°C/45% RH). Zone II = Subtropical/Mediterranean (25°C/60% RH). Zone III = Hot and dry (30°C/35% RH). Zone IVA = Hot and humid (30°C/65% RH).

Step 3: Read the question carefully.
The question asks about Zone II (Subtropical/Mediterranean). This zone corresponds to 25°C/60% RH.

Step 4: Eliminate wrong options.
Option 1 (21°C/45% RH) is Zone I. Option 2 (30°C/35% RH) is Zone III. Option 3 (30°C/65% RH) is Zone IVA.

Step 5: Confirm.
Zone II storage condition is 25°C/60% RH. This is also the long-term stability condition used in many countries.


Answer: Option (4) — 25°C / 60% RH