How to fix the concentration for RS by HPLC

Answer Posted / kanta

Formula=Estimation LOQ concentration (PPM)X1/Desired LOQ concentration (%)X100.
For example as per ICHQ3B our product Reporting threshold was 0.05% this is called Desired LOQ concentration.First initially we fix sample concentration as 500 ppm.This is 100%,as per this, 0.05% LOQ ppm was 0.25 ppm this is Estimated LOQ concentration.

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