From: Multi-patient dose synthesis of [18F]Flumazenil via a copper-mediated 18F-fluorination
Control | Method | Acceptance criteria | Trasis Results (n = 5) | Cardiff Results (n = 3) |
---|---|---|---|---|
RCY (n.d.c) | Ionization chamber | N/A | 43 ± 2% | 35 ± 5% |
Appearance | Organoleptic | Clear and colorless | Clear and colorless | Clear and colorless |
pH | pH-meter | 4.5 to 8.5 | 7.07 ± 0.03 | 7.5 |
Chemical purity | HPLC | [19F]FMZ ≤ 50 µg/V | [19F]FMZ 1.1 ± 0.4 µg/V OHMZ 3.7 ± 0.8 µg/V | [19F]FMZ ≤ 1.5 µg/V OHMZ ≤ 1.5 µg/V |
Spot test | TBA-HCO3 ≤ 2.6 mg/V | TBA-HCO3 ≤ 1.3 mg/V | TBA-HCO3 ≤ 2.6 mg/V | |
Test strips | Copper (as Cu2+) ≤ 340 µg/V | Copper (as Cu2+) ≤ 100 µg/V | Copper (as Cu2+) ≤ 100 µg/V | |
Radiochemical purity | Radio-TLC | [18F]flumazenil ≥ 95% [18F]fluoride ≤ 5% | [18F]flumazenil ≥ 98% [18F]fluoride ≤ 2% | [18F]flumazenil ≥ 99% [18F]fluoride ≤ 1% |
Radio-HPLC | [18F]flumazenil ≥ 99% | [18F]flumazenil > 99% | [18F]flumazenil > 99% | |
Residual solvent | GC | DMA ≤ 1090 ppm Acetonitrile ≤ 410 ppm Pyridine ≤ 200 ppm Ethanol ≤ 10% v/v (excipient) | DMA ≤ 50 ppm (LOQ) Acetonitrile ≤ 100 ppm Pyridine ≤ 50 ppm (LOQ) Ethanol = 6.5 ± 0.5 v/v | DMA ≤ 20 ppm (LOQ) Acetonitrile ≤ 100 ppm Pyridine ≤ 20 ppm (LOQ) Ethanol ≤ 10% v/v |