Review Article
Analytical Quality by Design: A Tool for Regulatory Flexibility and Robust Analytics
Table 4
Type of method performance characteristics as per USP and ICH Q2 (R1).
| S. number | Method performance characteristics | Defined by ICH and USP |
| 1 | Accuracy, specificity, and linearity | Systematic variability | 2 | Precision, detection limit, and quantification limit | Inherent random variability | 3 | Range and robustness | Not applicable |
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