Extraction Stability Calculation

FDA requires that the sponsor should assess the stability of processed samples, including the residence time in the autosampler against freshly prepared calibrators

High QC

True Concentration Measured Concentration 1 Measured Concentration 2 Measured Concentration 3

Medium QC

True Concentration Measured Concentration 1 Measured Concentration 2 Measured Concentration 3

Low QC

True Concentration Measured Concentration 1 Measured Concentration 2 Measured Concentration 3
QC Level Mean Accuracy Standard Deviation CV (%)
High QC
Medium QC
Low QC