The FDA requires that the sponsor should demonstrate the stability of extracts in the autosampler only if the autosampler storage conditions are different or not covered by extract (processed sample) stability.
| True Concentration | Measured Concentration 1 | Measured Concentration 2 | Measured Concentration 3 |
|---|---|---|---|
| True Concentration | Measured Concentration 1 | Measured Concentration 2 | Measured Concentration 3 |
|---|---|---|---|
| True Concentration | Measured Concentration 1 | Measured Concentration 2 | Measured Concentration 3 |
|---|---|---|---|
| QC Level | Mean Accuracy | Standard Deviation | CV (%) |
|---|---|---|---|
| High QC | |||
| Medium QC | |||
| Low QC |