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