I am in the process of creating an analytical method for the technicians to run following a USP 36 monograph. The steps i have taken are
Developing the method on to hard copy with slight changes to the column .The API is Minoxidil.
Validating the method
Now the QA has come back and updated the method requesting linearity run for every time the Assay is done . Now my question is, since we have already implemented this in the method validation , is this still required in an assay after the fact?
In my years of practice i have not seen this and the new QA is requesting this. adding this can not only add cost to the test but also time. USP 36 only specifies System Suitability with requirements of a resolution and a relative standard deviation but no linearity.
Please let me know your thoughts on this.