Question

According to the ICH guidelines for stability studies, Climatic Zone II temperature and relative humidity are respectively:

• A. $ 25^\circ C $ and RH $ 60\% $
• B. $ 30^\circ C $ and RH $ 65\% $
• C. $ 40^\circ C $ and RH $ 75\% $
• D. $ 25^\circ C $ and RH $ 75\% $

Hint:

Zone II is applicable to Europe, Japan, and parts of India — important for multinational drug stability protocols.

Answer 1

The Correct Option is A

- 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.