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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