Calibration Curve
Data Entry
Unknown samples (optional)
What it does
Fits a straight line (response = a + S·concentration) to calibration standards by ordinary least squares, reports the slope and intercept with confidence intervals, r², the residual standard deviation sy/x, and derives the detection and quantitation limits from the curve. Every standard is back-calculated so that accuracy per level can be checked.
Typical uses
- UV/Vis, HPLC or fluorescence calibration for assay, content uniformity and dissolution testing
- Linearity and range sections of an ICH Q2(R2) validation report
- Checking day-to-day curves: slope drift, intercept bias, RSD of replicate standards
How to read the output
- r² alone is not linearity. Look at the residual-% plot: a systematic curve means the range is too wide or the detector saturates. r² ≥ 0.99 is a common acceptance value, not a proof.
- Intercept test: if the intercept differs significantly from zero, single-point calibration or "response factor" quantitation will be biased at low concentrations.
- LOD = 3.3·σ/S, LOQ = 10·σ/S with σ = sy/x (ICH Q2(R2) "standard deviation of the response and the slope"). They are estimates; ICH expects the LOQ to be confirmed by analysing standards at that level with acceptable precision and accuracy. The intercept standard deviation may be used as σ instead; the residual SD is used here because it does not depend on the concentration spacing.
- Back-calculated accuracy: the FDA/EMA bioanalytical limits (±15%, ±20% at the lowest standard) are used to highlight levels; pharmacopoeial assay methods usually require tighter agreement.
- Replicate RSD per level flags precision problems at individual standards.
Prerequisites and limitations
- At least three, preferably five or more concentration levels spanning 80–120 % of the working range (ICH Q2(R2)); replicates entered as separate rows
- Constant variance across the range. If the residual-% plot shows a funnel, weighted (1/x, 1/x²) regression is more appropriate; this tool fits unweighted OLS only
- Do not extrapolate below the lowest or above the highest standard
References: ICH Q2(R2) Validation of Analytical Procedures (2023); Miller J.N., Miller J.C. (2018) Statistics and Chemometrics for Analytical Chemistry, 7th ed., Pearson; Shrivastava A., Gupta V.B. (2011) Chron. Young Sci. 2:21–25, doi:10.4103/2229-5186.79345.