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Table 1 Acceptance criteria and analytical data

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