Method Validation VALIDATION SUMMARY
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Validation Summary

Aggregate scorecard for all eight ICH Q2 validation parameters. Select the method type — acceptance criteria, metrics, and example values update automatically.

01 Specificity ✓02 Linearity ✓03 Accuracy ✓04 Repeatability ✓05 Intermediate Precision ✓06 LOD / LOQ ✓07 Range ✓08 Robustness ✓
8 pass
01 Specificity calculator
PASS ✓
Matrix effect % ≤ 10 %
ICS recovery % 80–120 %
Blank < LOD Must be Yes
02 Linearity calculator
PASS ✓
r² ≥ 0.999
Max |residual| % ≤ 2 %
03 Accuracy calculator
PASS ✓
Recovery at LOQ % 80–120 %
Recovery at spec % 90–110 %
Recovery RSD % ≤ 10 %
04 Repeatability calculator
PASS ✓
RSD at LOQ % ≤ 10 %
RSD at spec level % ≤ 5 %
05 Intermediate Precision calculator
PASS ✓
Combined RSD % ≤ 10 %
06 LOD / LOQ calculator
PASS ✓
LOQ / spec × 100 % ≤ 10 %
Confirmation RSD % ≤ 10 %
Confirmation recovery % 80–120 %
07 Range calculator
PASS ✓
Lower boundary passes Must be Yes
Upper boundary passes Must be Yes
08 Robustness calculator
PASS ✓
Max |factor effect| % ≤ 2 %
IS recovery min % ≥ 85
IS recovery max % ≤ 115 %
Quick Reference
ParameterStatus
01 Specificity
✓
02 Linearity
✓
03 Accuracy
✓
04 Repeatability
✓
05 Intermediate Precision
✓
06 LOD / LOQ
✓
07 Range
✓
08 Robustness
✓
✓
METHOD VALIDATED
All 8 parameters pass
The trace impurity method is fully validated. Ongoing system suitability (CCV, IS recovery, calibration verification) provides daily evidence that the method continues to perform as validated.