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Table 2 ICH table adapted to radiopharmaceuticals

From: EANM guideline on the validation of analytical methods for radiopharmaceuticals

Type of analytical procedureRadioactivity 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++++
  1. (+) not always possible (e.g. short half life, see text)
  2. aradioenantiomeric purity measurements should be validated analogously