I am doing the stability study of volumetric solution; on the basis of that study i am giving the 1 month use before date to the solution. In between 1 month period i was check the normality of these solution after some interval, there is no any drastic change in the normality;(RSD limit- NMT 0.2%). All result are within the RSD limit.
On the basis of these study, it is regulatory requirement to give the restandardization date to these vol. solution?????
It is acceptable only use before date.
some auditor suggest that give the restandardization date to these solution.
So my question is that, then what is the use of the stability study?????????