From: Automated GMP compliant production of [18F]AlF-NOTA-octreotide
Validation parameters | Results |
---|---|
HPLC method | |
 Specificity | The method is specific for [18F]AlF-NOTA-octreotide, NOTA-octreotide, metal complexes of NOTA-octreotide and octreotide (resolution ≥1.5) |
 Linearity | The method is linear in the tested range Range 2.01–29.92 μg/mL, R2 > 0.995 for NOTA-octreotide |
 Method precision | 6 repeated injections of 20 μL of a 5.026 μg/mL NOTA-octreotide solution yield a % RSD AUC of 3.5% and a % RSD of retention time of 0.2%. |
 Quantification and detection limits of NOTA-octreotide, AlF-NOTA-octreotide and metal complexes of NOTA-octreotidea | LOD = 0.30 μg/mL |
LOQ = 1.0 μg/mL | |
 Recovery [18F]F−, [18F] AlF and [18F]AlF-NOTA-octreotide | 99.0 ± 1.4%, 100.1 ± 1.1% and 101.9 ± 1.8% |
GC method | |
 Specificity | The method is specific for EtOH |
 Linearity | R2 > 0.99 for all tested solvents, range: 0.005% to 5% for CH3CN and DMSO; 0.005% to 10% for EtOH |
 Method precision | The % RSD of the AUC was < 5% and the %RSD of the retention time was < 1% for all tested solvents. |
 Quantification and detection limits | LOD EtOH: 0.0006%; LOQ EtOH: 0.0020% |