Question

Which is the correct long-term stability condition for zone IVb?

• A. \( 40^\circ C \pm 2^\circ C / 75% \pm 5% \)
• B. \( 30^\circ C \pm 2^\circ C / 65% \pm 5% \)
• C. \( 30^\circ C \pm 2^\circ C / 75% \pm 5% \)
• D. \( \text{None} \)

Hint:

Long-term stability testing ensures drug formulations retain their potency and physical characteristics over time.

Answer 1

The Correct Option is C

Zone IVb stability conditions (30°C ± 2°C / 75% ± 5%) are designated for hot and humid climates, ensuring pharmaceutical product integrity. These guidelines regulate storage and shelf-life to prevent degradation in high-temperature environments. They help maintain therapeutic efficacy under tropical storage conditions.