Restandardization of Volumetric solution

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???

Stability study of volumetric is used to determine the standardization of the solutions. In some companies, it is called volumetric solution hold time study or shelf life of solutions.

Ok sir…But it is required to do the restandardization in between 1 month period.

Please follow

Dear Ankur,

For the determination of shelf life of volumetric solution the, the shelf life to be determine at the interval of 3 day for 15 days and the RSD of 5 value should be less than 1.0 % . Can you provide us the guideline or literature for assigning the limit of 1.0% .

Yes it is regulatory requirements. U have to check the shelf life or strength or performence of the solutions for intended uses as per CFR21- 211. 160 (b) & 211.194.
Crossed fingers