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EJNMMI Radiopharmacy and Chemistry

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

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

–

+

–

+

  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
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