Open Access

Table 2

Validation characteristics according to the nature of the test.

Type of analytical procedure characteristics Identification Testing for impurities Assay dissolution
(measurement only)

    Quantitative Limit  
Accuracy + +
Repeatability + +
Intermediate precision + (1) + (1)
Specificity (2) + + + +
Detection limit − (3) +
Quantitation limit +
Linearity + +
Range + +
Robustness + +

− signifies that this characteristic is not normally evaluated; + signifies that this characteristic is normally evaluated; (1) in cases where reproducibility (see glossary) has been performed, intermediate precision is not needed [8]; (2) lack of specificity of one analytical procedure could be compensated by other supporting analytical procedure(s); (3) may be needed in some cases.

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