EUROPEAN PHARMACOPOEIA 5.

0 Xenon (
133
Xe) injection
Bacterial endotoxins (2.6.14) : less than 175/V IU/ml, V
being the maximum administered volume in millilitres. The
injection may be released for use before completion of the
test.
CHEMICAL PURITY
(a) Ammonium (2.4.1). 1 ml complies with the limit test for
ammonium (10 ppm).
(b) Nitrates. To 1 ml add 49 ml of nitrate-free water R. Place
5 ml of this solution in a test-tube immersed in iced water,
add 0.4 ml of a 100 g/l solution of potassium chloride R,
0.1 ml of diphenylamine solution R and, dropwise with
shaking, 5 ml of sulphuric acid R. Transfer the tube to a
water-bath at 50 C. After 15 min, any blue colour in the
solution is not more intense than that in a standard prepared
at the same time in the same manner using a mixture of
4.5 ml of nitrate-free water R and 0.5 ml of nitrate standard
solution (2 ppm NO
3
) R (10 ppm).
The injection may be released for use before completion of
tests (a) and (b).
RADIONUCLIDIC PURITY
Record the gamma-ray spectrum using a suitable instrument.
The spectrum does not differ significantly from that of a
standardised fluorine-18 solution. Standardised fluorine-18
solutions are available from the laboratories recognised by
the competent authority.
The half-life is between 1.9 min and 2.2 min. Not less than
99 per cent of total radioactivity corresponds to oxygen-15.
The injection may be released for use before completion of
the test.
RADIOCHEMICAL PURITY
Examine by liquid chromatography (2.2.29).
Test solution. The preparation to be examined.
The chromatographic procedure may be carried out using:
a column 0.25 m long and 4.0 mm in internal
diameter packed with aminopropylsilyl silica gel for
chromatography R (10 m),
as mobile phase at a flow rate of 1 ml/min a 10 g/l
solution of potassium dihydrogen phosphate R adjusted
to pH 3 with phosphoric acid R,
a suitable radioactivity detector,
a loop injector,
an internal recovery detection system, consisting of a
loop of the chromatographic tubing between the injector
and the column through the radioactivity detector, which
has been calibrated for count recovery,
maintaining the column at a constant temperature between
20 C and 30 C.
Inject the test solution. Continue the chromatography
for 10 min. In the chromatogram obtained, the first peak
corresponds to the injected radioactivity of the test solution,
the second peak corresponds to the amount of radioactivity
as [
15
O]water. Calculate the percentage content of [
15
O]water
from the areas of the peaks in the chromatogram obtained
with the test solution. Not less than 99 per cent of the total
radioactivity injected corresponds to oxygen-15 in the form
of water.
The injection may be released for use before completion of
the test.
RADIOACTIVITY
Measure the radioactivity using suitable equipment by
comparison with a standardised fluorine-18 solution or
by using an instrument calibrated with the aid of such a
solution.
01/2005:0133
XENON (
133
Xe) INJECTION
Xenoni (
133
Xe) solutio iniectabilis
DEFINITION
Xenon (
133
Xe) injection is a sterile solution of xenon-133 that
may be made isotonic by the addition of sodium chloride.
Xenon-133 is a radioactive isotope of xenon and is obtained
by separation from the other products of uranium fission.
The injection contains not less than 80 per cent and not more
than 130 per cent of the declared xenon-133 radioactivity at
the date and hour stated on the label.
The injection is presented in a container that allows the
contents to be removed without introducing air bubbles.
The container is filled as completely as possible and any gas
bubble present does not occupy more than 1 per cent of
the volume of the injection as judged by visual comparison
with a suitable standard.
CHARACTERS
A clear, colourless solution.
Xenon-133 has a half-life of 5.29 days and emits beta and
gamma radiation and X-rays.
IDENTIFICATION
Record the gamma-ray and X-ray spectrum using a suitable
instrument. The spectrum does not differ significantly
from that of a standardised xenon-133 solution in a 9 g/l
solution of sodium chloride R, apart from any differences
attributable to the presence of xenon-131m and xenon-133m.
If standardised xenon-133 solutions are not readily available,
suitable standardised ionisation chambers are obtainable
from laboratories recognised by the relevant competent
authority. The most prominent gamma photon of xenon-133
has an energy of 0.081 MeV and there is an X-ray (resulting
from internal conversion) of 0.030 MeV to 0.035 MeV.
Xenon-131m has a half-life of 11.9 days and emits a gamma
photon of 0.164 MeV. Xenon-133m has a half-life of 2.19 days
and emits a gamma photon of 0.233 MeV.
TESTS
pH (2.2.3). The pH of the injection is 5.0 to 8.0.
Sterility. It complies with the test for sterility
prescribed in the monograph on Radiopharmaceutical
preparations (0125). The injection may be released for use
before completion of the test.
RADIONUCLIDIC PURITY
(a) Record the gamma-ray and X-ray spectrumusing a suitable
instrument. The spectrum does not differ significantly from
that of a standardised xenon-133 solution in a 9 g/l solution
of sodium chloride R, apart from any differences attributable
to the presence of xenon-131m and xenon-133m.
(b) Transfer 2 ml of the injection to an open flask and
pass a current of air through the solution for 30 min,
taking suitable precautions concerning the dispersion of
radioactivity. Measure the residual beta and gamma activity
of the solution. The activity does not differ significantly from
the background activity detected by the instrument.
RADIOACTIVITY
Weigh the container with its contents. Determine its
total radioactivity using suitable counting equipment by
comparison with a standardised xenon-133 solution or by
measurement in an instrument calibrated with the aid of
such a solution, operating in strictly identical conditions. If
an ionisation chamber is used its inner wall should be such
General Notices (1) apply to all monographs and other texts 869
Xenon (
133
Xe) injection EUROPEAN PHARMACOPOEIA 5.0
that the radiation is not seriously attenuated. Remove at
least half the contents and re-weigh the container. Measure
the radioactivity of the container and the remaining contents
as described above. From the measurements, calculate the
radioactive concentration of xenon-133 in the injection.
CAUTION
Significant amounts of xenon-133 may be present in the
closures and on the walls of the container. This must be
taken into account in applying the rules concerning the
transport and storage of radioactive substances and in
disposing of used containers
870 See the information section on general monographs (cover pages)