Table 4 Final product specifications of [¹⁸F]Flurpiridaz (7)

Appearance

Visual

Clear, Colorless, or Light Yellow

Clear, Colorless, or Light Yellow

pH

pH-Indicator Strip

4.5–8.5

6–7

Half-Life

Half-Life Measurement

105–115 min

109 min

Radiochemical Purity

Radio-HPLC

 > 95%

98.5%

Radionuclidic Purity

Gamma Spec

 > 99.9%

 > 99.9%

Precursor

HPLC

N.D

N.D

(TBA)

Spot Test

 ≤ 2.6 mg/V

 ≤ 2.6 mg/V

Ethanol

GC

 ≤ 10% (h/h)

8.2% (h/h)

Acetonitrile

GC

 ≤ 4.1 mg / V

0.04 mg / V

Ascorbic Acid

HPLC

 ≤ 500 mg / V

151 mg / V

BET

LAL

 < 175 IU/V

 < 175 IU/V

Sterility

Sterility Test

Sterile

Sterile