Table 2
Validation characteristics according to the nature of the test.
| Type of analytical procedure characteristics | Identification | Testing for impurities | Assay dissolution (measurement only) Content/potency |
||
|---|---|---|---|---|---|
| Quantitative | Limit | ||||
| Accuracy | – | + | – | + | |
| Precision | |||||
| 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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