Related substance by HPLC

[mohammad]

Dears,

As per the EP monograph for related substances by HPLC for any molecule.
Do we need to check the %RSD of refernce solution diluted from test solution (Example : 0.1% or any other concentration with respect to test concentration). If yes, how many injections. & what wil be the limit for RSD.
Since the EP says just inject refernce solution.
Any refernce shall be highly appreciated.


Mohammad.

[Perreman]

EP usually states some sort of system suitability, you should be able to find the information on what to relate your reference solution to. It's often a %RSD criteria for 6 injections, a resolution criteria between two peaks or something like that.

What monograph are you using?