Table 2 Model calculation for maximum allowed HEPES concentration and determination of HEPES content in exemplary [68Ga]Ga-Pentixafor product samples measured with HPLC and TLC (ImageJ)
From: Development and evaluation of a rapid analysis for HEPES determination in 68Ga-radiotracers
Model calculation | |||
Product activity | Product volume | Activity for administration | Calculated max. HEPES concentration |
900 MBq | 16 mL | 150 MBq (in 2.67 mL) | 200 μg/2.67 mL = 75 μg/mL |
Determination of HEPES concentration in a radiopharmaceutical | |||
Method | [68Ga]Ga-Pentixafor 1 [μg/mL] | [68Ga]Ga-Pentixafor 2 [μg/mL] | [68Ga]Ga-Pentixafor 3 [μg/mL] |
TLC (Ph. Eur.) | 169.4 (no release) | 23.7 | 2.6 |
TLC (improved) | 71.6 | 23.9 | 6.6 |
HPLC (Antunes et al.) | 65.97 | 19.17 | 8.83 |