Quality Control Tests

Ph.Eur 8.0

Ethanol 10% in water for injections (n = 6)

Ethanol 8% in saline (n = 11)

Corrected yield (%)

Not applicable

27± 7

23 ± 3

Specific activity in the end of synthesis (GBq/μmol)

Not applicable

>117.1

>178.6

pH

4.5 to 8.5

4.54 to 7.03

4.57 to 7.06

Residual Solvents (Acetonitrile) (%V/V)

<0.04

0.00012 to 0.00193

0.00096 to 0.0067

Ethanol Determination (%V/V)

<10% or 2.5 g per administration

6.15 to 8.99

5.81 to 8.07

Radiochemical Purity (%)

>95%

98.43 to 99.40

98.43 to 99.19

Radionuclidic Identity (min)

105 to 115

109.56 to 110.70

109.30 to 113.08

Radionuclidic Purity (%)^*

>99.9%

99.86 to 99.99

99.70 to 100.00

Chemical Purity

Tetrabutylammonium (μg/mL)

<2.6 mg/V^**

<50

<50

Thymine (μg/mL)

Any other impurities, for each one < 0.1 mg/V^**

0.089 to 0.898

0.081 to 0.146

Thymidine (μg/mL)

0.129 to 0.176

0.096 to 0.176

Chlorothymidine (μg/mL)

0.132 to 0.532

0.148 to 0.425

Stavudine (μg/mL)

<0.1 mg/V^**

0.023 to 0.061

0.019 to 0.040

Fluorothymidine (μg/mL)

<0.1 mg/V^**

0.178 to 0.466

0.057 to 0.509

Bacterial Endotoxin (EU/mL)

<175/V^**

<5.00

<5.00

Sterility

Sterile

Pass

Pass