Table 2 ICH table adapted to radiopharmaceuticals
From: EANM guideline on the validation of analytical methods for radiopharmaceuticals
Type of analytical procedure | Radioactivity Content (assay) | Radionuclide identity (approx. t½) | Radionuclide identity (spectrometry) | Radiochemical identity (HPLC/TLC) | Radionuclidic purity (limit test) | Radionuclidic purity (spectrometry after decay) | Radiochemical puritya (HPLC/TLC) |
|---|---|---|---|---|---|---|---|
Characteristics | |||||||
Accuracy | + | – | + | – | + | + | + |
Precision (Repeatability) | + | + | – | – | – | (+) | (+) |
Intermediate Precision | – | – | – | – | – | (+) | (+) |
Specificity | + | + | + | + | + | + | + |
Detection Limit | – | – | – | – | + | – | – |
Quantification Limit | – | – | – | – | – | + | + |
Linearity | + | + | – | – | – | + | + |
Range | + | + | – | – | – | + | + |