Table 2 Quality control parameters for all released batches (n = 81) of [11C]metoclopramide according to the recommendations of the European Pharmacopoeia for 11C-radiotracers
From: Pitfalls and solutions of the fully-automated radiosynthesis of [11C]metoclopramide
Quality control parameter | Release criteria | Quality control |
|---|---|---|
Radiochemical purity | > 95% | 99 ± 1% |
Molar activity | no release criteria | 132 ± 164 GBq/μmol |
Half-life | 20.3 ± 2.0 min | 19.4 ± 0.8 min |
Radionuclidic purity (y-line) | 430–520 keV | 505 ± 15 keV |
Residual solvents | < 410 ppm per solvent | < 410 ppm butanone |
< 410 ppm acetonitrile | ||
< 10% ethanol | < 10% ethanol | |
pH | 4.5–8.5 | 7.5 ± 0.2 |
Osmolality | 200–400 mosm/kg | 316 ± 37 mosm/kg |
Sterility | pass | pass |
Endotoxins | Pass | pass |