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Table 1 Characteristics to be validated following ICH Q2(R1)

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

 Type of analytical procedure
IdentificationTesting for impuritiesAssay
QuantitativeLimitDissolution Measurement only
Content / potency
Characteristic
 Accuracy++
 Precision
  Repeatability++
  Intermediate Precision +a +a
 Specificityb++++
 Detection Limit-c+
 Quantification Limit+
 Linearity++
 Range++
  1. – signifies that this characteristic is not normally evaluated
  2. + signifies that this characteristic is normally evaluated
  3. ain cases where reproducibility has been tested, intermediate precision is not needed
  4. black of specificity of one analytical procedure could be compensated by other supporting analytical procedure(s)
  5. cmay be needed in some cases