Free calculators for every ICH Q2(R2) / USP <1225> method validation parameter — System Suitability, Specificity, Linearity, Range, Accuracy, Precision, Solution Stability, Robustness, and LOD & LOQ. Pick the calculator you need below.
A quick reference for what each parameter measures and where it fits in an Analytical Method Validation / Verification protocol.
Confirms the chromatographic/analytical system itself is performing correctly, via %RSD and %CV of replicate injections, before any method validation run.
Confirms the method accurately measures the analyte in the presence of expected interferents — blank, placebo, and degradation products.
Demonstrates response is directly proportional to analyte concentration across the working range, via correlation coefficient and regression.
The interval between upper and lower analyte concentrations shown to have suitable linearity, accuracy, and precision.
Closeness of the measured value to the true/reference value, expressed as % Recovery across spike levels.
Degree of agreement among repeat measurements — Repeatability (intra-day), Reproducibility Precision (Different Lab) and Intermediate Precision (inter-day).
Confirms standard and sample solutions remain stable, within acceptance limits, over the intended analysis time window.
Measures method reliability under small, deliberate variations in operating conditions — flow rate, mobile phase, wavelength, temperature.
Limit of Detection and Limit of Quantitation — the lowest analyte amount reliably detected and reliably quantified.