Stability Condition for India General Case

Hello Ankur,
I have a query regarding the stability condition for India (Zone-IV b). As per my understanding, the stability condition for the general case should be as below:
Long term: 30°C ±2°C / 75% RH ±5% RH &
Accelerated: 40°C ± 2° C / 75% RH ± 5% RH
And, no intermediate study is applicable for Zone-IV b.

While referring the WHO guideline Annex 2 to WHO Technical Report Series, No. 953 I found the stability condition mentioned for India is 30 °C/ 70% RH.

The query is what is the correct RH for India ****70% or 75%?
And, is there a need for study at intermediate condition?



Hi Amour sir,

I am also having same question

75%RH is applicable for INDIA. Refer ICH Guideline