If USP monograph of Acyclovir Tablets USP says storage condition is 15-25 C but if we export the acyclovir tablet to Yemen ( ICH IV a zone i.e 30) then what will be the storage condition on the label?
In my opinion, label storage condition should be as per USP storage requirements. Zone categories are based on the stability studies requirements. Zones guides us for the conditions upon which the Stability studies needs to be carried out for different stability conditions.
@deep thank you for your reply.
But can you please tell about the IH products for the satbility.
IH means In-house products ? Of yes then stability conditions to be chosen based on the market requirements.
can you elaborate the market requirements.