Product is studied for 30/75 and 40/75 condition in transferring unit now we want to study product at 30/65 instead of 30/75 for long term for domestic market in receiving unit it is acceptable?
Justification :the product is stable for 30/75
Also we are performing study at 40/75
Label storage: store in Cool place.
We are submitting product to domestic not to RoW market.
You should collect long term stability data according to the Climatic Zone your domestic market belongs too.
Climatic Zone IV A is 30C/65RH, IV B is 30C/75RH. Globally many countries fall into IVA. ASEAN countries like Philippines, Thailand, Vietnam are IVB.
As per ICH Q1A R2 you can substitute 30C/65RH for 25C/60RH which is Zone II for Europe and North America. Hence 30C/65RH can satisfy the majority of regions.
2 Likes