monograph on 68Ga

Gallium (68Ga) chloride solution for radiolabelling
Reference: PA/PH/Exp. 14/T (08) 21 ANP
NOTE ON THE MONOGRAPH
The radionuclide gallium-68 is obtained by elution of a
68
Ge/68Ga generator using dilute hydrochloric acid. To
ensure a sufficiently low level of the parent radionuclide
germanium-68, the gallium-68 can either be adsorbed in the
form of [GaCl4]− on an anion exchange column followed by
elution from the column in the form of Ga3+ cations with water
or diluted hydrochloric acid, or be adsorbed in the form of
trivalent gallium on a cation exchange column followed by
elution with an acetone/hydrochloric acid mixture.
XXXX:2464
GALLIUM (68Ga) CHLORIDE SOLUTION
FOR RADIOLABELLING
Gallii (68Ga) chloridi solutio ad
radio-signandum
68
GaCl3
Mr 174.3
DEFINITION
Solution containing gallium-68 in the form of gallium chloride in
dilute hydrochloric acid. The preparation may contain acetone.
Content :
— gallium-68 : 90 per cent to 110 per cent of the declared
gallium-68 radioactivity at the date and time stated on the
label.
TESTS
pH : maximum 2, using a pH indicator strip R.
Bacterial endotoxins (2.6.14) : less than 175 IU/V, V being the
maximum volume to be used for the preparation of a single
patient dose, if intended for use in the manufacture of parenteral
preparations without a further appropriate procedure for the
removal of bacterial endotoxins. The solution may be released
for use before completion of the test.
Iron : maximum 10 μg/GBq.
Atomic absorption spectrometry (2.2.23, Method I).
Modifier solution : 14 g/L solution of magnesium nitrate R.
Test solution. Dilute the solution to be examined with a 1 per
cent V/V solution of nitric acid R to obtain a radioactivity
concentration of 2.5 MBq/mL.
Reference solutions. Prepare the reference solutions using iron
standard solution (20 ppm Fe) R, diluted as necessary with a
1 per cent V/V solution of nitric acid R(28).
Source: iron hollow-cathode lamp.
Wavelength : 248.3 nm.
Atomisation device : graphite furnace.
An example of the injection and instrument parameters for the
graphic furnace atomic absorption analysis is shown below.
Internal and external protective gas : argon R.
Injection : 20 μL of the corresponding solution + 1 μL of the
matrix modifier solution.
Injection temperature: 20 °C.
Furnace programme :
CHARACTERS
Appearance : clear, colourless solution.
Half-life and nature of radiation of gallium-68 : see general
chapter 5.7. Table of physical characteristics of radionuclides.
IDENTIFICATION
A. Test A for radionuclidic purity (see Tests) .
B. Determine the approximate half-life by no fewer than 3
measurements of the activity of a sample in the same
geometrical conditions within a suitable period of time (for
example, 15 min).
Result : 62 min to 74 min.
C. pH (see Tests).
D. To a volume of 20-100 μL(26) of the solution to be examined
add 1 mL of a 1.03 g/L solution of hydrochloric acid R.
Apply this solution to the top of a column containing strong
cation-exchange resin R(27), push 5 mL of air through the
column and collect the eluate. Determine the radioactivity
of the eluate (A1). Elute the column with 1 mL of a
1.03 g/L solution of of hydrochloric acid R. Determine
the radioactivity of the eluate (A2). Elute the column with
1 mL of a mixture of 2 volumes of hydrochloric acid R and
98 volumes of acetone R and push 5 mL of air through the
column. Determine the radioactivity of the eluate (A3) and
the residual activity on the column (A4).
Calculate the percentage of radioactivity in the A3 eluate
using the following expression :
Final temperature
(°C)
Ramp time
(s)
Hold time (s)
Internal
protection
gas flow
(mL/min)
Drying
110
1
30
250
Drying
130
15
30
250
Pyrolysis
1400
10
20
250
Atomisation
2100
0
5
0
Clean out
2450(29)
1
3
250
Zinc : maximum 10 μg/GBq.
Atomic absorption spectrometry (2.2.23, Method I).
Test solution. Dilute the solution to be examined with a 1 per
cent V/V solution of nitric acid R to obtain a radioactivity
concentration of 50 MBq/mL.
Reference solutions. Prepare the reference solutions using zinc
standard solution (10 ppm Zn) R, diluted as necessary with a
1 per cent V/V solution of nitric acid R(30).
Source: zinc hollow-cathode lamp.
Wavelength : 213.9 nm.
Atomisation device : air-acetylene flame.
RADIONUCLIDIC PURITY
The preparation may be released for use before completion of
test B.
Gallium-68 : minimum 99.9 per cent of the total radioactivity.
Result : the percentage of radioactivity in the A3 eluate is not A. Gamma-ray spectrometry.
less than 90 per cent.
Result : the gamma photons have energies of 0.511 MeV and
1.077 MeV ; depending on the measurement geometry, a sum
E. To 100 μL of silver nitrate solution R2 add 50 μL of the
peak of 1.022 MeV may be observed.
solution to be examined. A white precipitate is formed.
(26)
(27)
(28)
(29)
(30)
The volume is chosen so as to allow measurement of the radioactivity with sufficient accuracy.
Strata X-C 33 μm 10 mg/mL (Phenomenex) is suitable.
Dilutions of 50 μL, 100 μL, 150 μL and 200 μL of the standard solution in 100.0 mL were suitable when using a Perkin Elmer AAnalyst 800 instrument.
Verify instrument temperature limits.
Dilutions of 2.0 mL, 4.0 mL, 6.0 mL, 8.0 mL and 10.0 mL of the standard solution in 100.0 mL were suitable when using a Perkin Elmer AAnalyst 800 instrument.
508
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