Xenon (133Xe) injection EUROPEAN PHARMACOPOEIA 11.

RADIOCHEMICAL PURITY TESTS

The preparation may be released for use before completion pH (2.2.3) : 5.0 to 8.0.
of the test.
Sterility. It complies with the test for sterility prescribed in
[ 15O]Water. Liquid chromatography (2.2.29). the monograph Radiopharmaceutical preparations (0125).
Test solution. The preparation to be examined. The preparation may be released for use before completion
Column : of the test.
– size : l = 0.25 m, Ø = 4.0 mm ; RADIONUCLIDIC PURITY
– stationary phase : aminopropylsilyl silica gel for A. Gamma-ray and X-ray spectrometry.
chromatography R (10 μm); Comparison : standardised xenon-133 solution in a 9 g/L
solution of sodium chloride R.
– temperature : constant, at 20-30 °C.
Result : the spectrum obtained with the preparation to be
Mobile phase : 10 g/L solution of potassium dihydrogen examined does not differ significantly from that obtained
phosphate R adjusted to pH 3 with phosphoric acid R. with a standardised xenon-133 solution in a 9 g/L solution
Flow rate : 1 mL/min. of sodium chloride R, apart from any differences attributable
Detection : suitable detector to determine the distribution to the presence of xenon-131m and xenon-133m.
of radioactivity and internal recovery detection system, B. Transfer 2 mL of the preparation to be examined to an
consisting of a loop of the chromatographic tubing between open flask and pass a current of air through the solution
the injector and the column through the radioactivity detector, for 30 min, taking suitable precautions concerning the
which has been calibrated for count recovery. dispersion of radioactivity. Measure the residual beta and
Run time : 10 min. gamma activity of the solution. The activity does not differ
Identification of peaks : in the chromatogram obtained with significantly from the background activity detected by the
the test solution, the 1st peak corresponds to the injected instrument.
radioactivity of the test solution, the 2nd peak corresponds toRADIOACTIVITY
the amount of radioactivity as [15O]water. Weigh the container with its contents. Determine its
Limit : total radioactivity using suitable counting equipment by
– [15O]water : minimum 99 per cent of the total radioactivity comparison with a standardised xenon-133 solution or by
due to oxygen-15. measurement in an instrument calibrated with the aid of such
a solution, operating in strictly identical conditions. If an
RADIOACTIVITY ionisation chamber is used its inner wall should be such that
Determine the radioactivity using a calibrated instrument. the radiation is not seriously attenuated. Remove at least half
the contents and re-weigh the container. Measure the total
residual radioactivity of the container and the remaining
contents as described above. From the measurements,
01/2008:0133 calculate the radioactive concentration of xenon-133 in the
corrected 7.0 preparation to be examined.

CAUTION
Significant amounts of xenon-133 may be present in the
closures and on the walls of the container. This must be taken
XENON (133Xe) INJECTION into account in applying the rules concerning the transport
and storage of radioactive substances and in disposing of used
containers
Xenoni (133Xe) solutio iniectabilis
IMPURITIES
DEFINITION A. xenon-131m.
Sterile solution of xenon-133 that may be made isotonic by the
addition of sodium chloride. 04/2019:2803
Xenon-133 : 80 per cent to 130 per cent of the declared
xenon-133 radioactivity at the date and time stated on the
label.
The injection is presented in a container that allows the
contents to be removed without introducing air bubbles. The YTTRIUM ( 90Y) CHLORIDE SOLUTION
container is filled as completely as possible and any gas bubble
present does not occupy more than 1 per cent of the volume FOR RADIOLABELLING
of the injection as judged by visual comparison with a suitable
standard. Yttrii (90Y) chloridi solutio ad
CHARACTERS radio-signandum
Appearance : clear, colourless solution. 90
YCl3 Mr 196.3
Half-life and nature of radiation of xenon-133 : see general [39271-65-3]
chapter 5.7. Table of physical characteristics of radionuclides.
DEFINITION
IDENTIFICATION
Sterile solution containing yttrium-90 derived from
Gamma-ray and X-ray spectrometry. fission-produced strontium-90, in the form of yttrium chloride
Comparison : standardised xenon-133 solution in a 9 g/L in dilute hydrochloric acid.
solution of sodium chloride R. Content :
Results : the most prominent gamma photon of xenon-133 has – yttrium-90 : 90 per cent to 110 per cent of the declared
an energy of 0.081 MeV and there is an X-ray (resulting from yttrium-90 radioactivity at the date and time stated on the
internal conversion) of 0.030 MeV to 0.035 MeV. label.

1334 See the information section on general monographs (cover pages)

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