Chromatography Forum

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.

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?