AMV - Method Precision Calculator
Assay Repeatability / Method Precision per USP <1225> / ICH Q2(R1)
Enter Standard Areas (min 5 injections). The Average Area will be used as the reference for Assay calculation.
| # | Injection Name | Area Response |
|---|---|---|
| 1 | Standard-1 | |
| 2 | Standard-2 | |
| 3 | Standard-3 | |
| 4 | Standard-4 | |
| 5 | Standard-5 |
Define the constant dilution volumes for the test samples.
| Sample | Weight (mg) | Area Inj-1 | Area Inj-2 | Avg Area | % Assay |
|---|---|---|---|---|---|
| Test-1 | |||||
| Test-2 | |||||
| Test-3 | |||||
| Test-4 | |||||
| Test-5 | |||||
| Test-6 |
About Method Precision (Repeatability)
Method Precision (also known as Repeatability) expresses the closeness of agreement (degree of scatter) between a series of measurements obtained from multiple samplings of the same homogeneous sample under the prescribed conditions.
According to ICH Q2(R1), precision should be assessed using:
a) A minimum of 9 determinations covering the specified range of the procedure (e.g., 3 concentrations/3 replicates each); or
b) A minimum of 6 determinations at 100% of the test concentration. (This tool supports option B).
Acceptance Criteria
For assay methods of major components (drug substances or products), the acceptance criteria is typically % RSD ≤ 2.0%.