From: EANM guideline on the validation of analytical methods for radiopharmaceuticals
Type of analytical procedure | ||||
---|---|---|---|---|
Identification | Testing for impurities | Assay | ||
Quantitative | Limit | Dissolution Measurement only Content / potency | ||
Characteristic | ||||
Accuracy | – | + | – | + |
Precision | ||||
Repeatability | – | + | – | + |
Intermediate Precision | – | +a | – | +a |
Specificityb | + | + | + | + |
Detection Limit | – | -c | + | – |
Quantification Limit | – | + | – | – |
Linearity | – | + | – | + |
Range | – | + | – | + |