EUROPEAN PHARMACOPOEIA 5.
0 Sodium phosphate (32P) injection
hour stated on the label. Not less than 95 per cent of the
radioactivity corresponds to technetium-99m in the form of
pertechnetate ion.
The radioactivity due to radionuclides other than
technetium-99m, apart from that due to technetium-99
resulting from the decay of technetium-99m is not greater
than that shown below, expressed as a percentage of the
total radioactivity and calculated with reference to the date
and hour of administration.
Molybdenum-99 0.1 per cent
Other radionuclidic impurities 0.01 per cent
The injection may be prepared from a sterile preparation of
molybdenum-99 under aseptic conditions.
CHARACTERS
A clear, colourless solution.
Technetium-99m has a half-life of 6.02 h and emits gamma
radiation.
IDENTIFICATION
A. Record the gamma-ray spectrum using a suitable
instrument. The spectrum does not differ significantly
from that of a standardised technetium-99m solution
either by direct comparison or by using an instrument
calibrated with the aid of such a solution. Standardised
technetium-99m and molybdenum-99 solutions are
available from laboratories recognised by the competent
authority. The most prominent gamma photon of
technetium-99m has an energy of 0.140 MeV.
B. Examine the chromatogram obtained in the test for
radiochemical purity. The distribution of radioactivity
contributes to the identification of the preparation.
TESTS
pH (2.2.3). The pH of the injection is 4.0 to 8.0.
Aluminium. In a test tube about 12 mm in internal diameter,
mix 1 ml of acetate buffer solution pH 4.6 R and 2 ml of a 1
in 2.5 dilution of the injection in water R. Add 0.05 ml of a
10 g/l solution of chromazurol S R. After 3 min, the colour
of the solution is not more intense than that of a standard
prepared at the same time in the same manner using 2 ml of
aluminium standard solution (2 ppm Al) R (5 ppm).
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
Preliminary test. To obtain an approximate estimate before
use of the injection, take a volume equivalent to 37 MBq
and record the gamma-ray spectrum using a sodium iodide
detector with a shield of lead, of thickness 6 mm, interposed
between the sample and the detector. The response in
the region corresponding to the 0.740 MeV photon of
molybdenum-99 does not exceed that obtained using 37 kBq
of a standardised solution of molybdenum-99 measured
under the same conditions, when all measurements
are expressed with reference to the date and hour of
administration.
Definitive test. Retain a sample of the injection for a
sufficient time to allow the technetium-99m radioactivity to
decay to a sufficiently low level to permit the detection of
radionuclidic impurities. All measurements of radioactivity
are expressed with reference to the date and hour of
administration.
General Notices (1) apply to all monographs and other texts
— Molybdenum-99. Record the gamma-ray spectrum of
the decayed material in a suitable instrument calibrated
using a standardised molybdenum-99 solution. The most
prominent gamma photons have energies of 0.181 MeV,
0.740 MeV and 0.778 MeV. Molybdenum-99 has a half-life
of 66.0 h. Not more than 0.1 per cent of the total
radioactivity is due to molybdenum-99.
— Other gamma-emitting impurities. Examine the
gamma-ray spectrum of the decayed material for the
presence of other radionuclidic impurities, which should,
where possible, be identified and quantified. The total
radioactivity due to other radionuclidic impurities does
not exceed 0.01 per cent of the total radioactivity.
RADIOCHEMICAL PURITY
Examine by descending paper chromatography (2.2.26).
Test solution. Dilute the injection with water R to a suitable
radioactive concentration.
Apply 5 µl of the test solution. Develop for 2 h using
a mixture of 20 volumes of water R and 80 volumes of
methanol R. Allow the paper to dry in air. Determine the
distribution of radioactivity using a suitable detector. Not
less than 95 per cent of the total radioactivity is found in
the spot corresponding to pertechnetate ion, which has an
Rf value of about 0.6.
RADIOACTIVITY
Measure the radioactivity using suitable counting equipment
by comparison with a standardised technetium-99m solution
or by measurement in an instrument calibrated with the aid
of such a solution.
01/2005:0284
SODIUM PHOSPHATE (32P) INJECTION
Natrii phosphatis (32P) solutio iniectabilis
DEFINITION
Sodium phosphate (32P) injection is a sterile solution of
disodium and monosodium (32P) orthophosphates made
isotonic by the addition of sodium chloride. Phosphorus-32
is a radioactive isotope of phosphorus and may be produced
by neutron irradiation of sulphur. The injection contains
not less than 90.0 per cent and not more than 110.0 per
cent of the declared phosphorus-32 radioactivity at the date
and hour stated on the label. Not less than 95 per cent
of the radioactivity corresponds to phosphorus-32 in the
form of orthophosphate ion. The specific radioactivity is
not less than 11.1 MBq of phosphorus-32 per milligram of
orthophosphate ion.
CHARACTERS
A clear, colourless solution.
Phosphorus-32 has a half-life of 14.3 days and emits beta
radiation.
IDENTIFICATION
A. Record the beta-ray spectrum or the beta-ray absorption
curve using a suitable method. The spectrum or curve
does not differ significantly from that of a standardised
phosphorus-32 solution obtained under the same
conditions. Standardised phosphorus-32 solutions are
available from laboratories recognised by the competent
authority. The maximum energy of the beta radiation is
1.71 MeV.
B. Examine the chromatogram obtained in the test for
radiochemical purity. The distribution of radioactivity
contributes to the identification of the preparation.
849
Strontium (89Sr) chloride injection EUROPEAN PHARMACOPOEIA 5.0

TESTS the total radioactivity is due to radionuclides other than

pH (2.2.3). The pH of the injection is 6.0 to 8.0. strontium-89. The specific radioactivity is not less than
1.8 MBq of strontium-89 per milligram of strontium. The
Phosphates. Dilute the injection with water R to give a injection contains 6.0 mg/ml to 12.5 mg/ml of strontium.
radioactive concentration of 370 kBq of phosphorus-32 per
millilitre. Mix in a volumetric flask, with shaking, 1.0 ml of CHARACTERS
the solution with a mixture of 0.5 ml of a 2.5 g/l solution of A clear, colourless solution.
ammonium vanadate R, 0.5 ml of ammonium molybdate Strontium-89 has a half-life of 50.5 days and emits beta
solution R and 1 ml of perchloric acid R and dilute to 5.0 ml radiation with a maximum energy of 1.492 MeV.
with water R. After 30 min, the solution is not more intensely
coloured than a standard prepared at the same time in the IDENTIFICATION
same manner using 1.0 ml of a solution containing 33 mg of A. Record the gamma-ray and X-ray spectrum using a
orthophosphate ion per litre. suitable instrument. The spectrum does not differ
Sterility. It complies with the test for sterility significantly from that of a standardised strontium-89
prescribed in the monograph on Radiopharmaceutical solution, when measured either by direct comparison
preparations (0125). The injection may be released for use or by using an instrument calibrated with the aid of
before completion of the test. such a solution. Standardised strontium-89 solutions are
available from laboratories recognised by the competent
RADIONUCLIDIC PURITY
authority. The gamma photon detected has an energy
Record the beta-ray spectrum or the beta-ray absorption of 0.909 MeV and is due to the short-lived daughter
curve using a suitable method. The spectrum or curve product, yttrium-89m (formed in 0.01 per cent of the
does not differ significantly from that of a standardised disintegrations), in equilibrium with the strontium-89.
phosphorus-32 solution obtained under the same conditions.
B. To 0.1 ml of the injection to be examined, add 1 ml of a
RADIOCHEMICAL PURITY freshly prepared 1 g/l solution of sodium rhodizonate R.
Examine by ascending paper chromatography (2.2.26). Mix and allow to stand for 1 min. A reddish-brown
Test solution. Dilute the injection with water R until the precipitate is formed.
radioactivity is equivalent to 10 000 to 20 000 counts per C. To 0.1 ml of silver nitrate solution R2 add 50 µl of the
minute per 10 µl injection to be examined. A white precipitate is formed.
Reference solution. Prepare a solution of phosphoric acid R
containing 2 mg of phosphorus per millilitre. TESTS
Using a strip of paper 25 mm wide and about 300 mm pH (2.2.3). The pH of the solution is 4.0 to 7.5.
long, apply 10 µl of the reference solution. Apply to the Note : the following tests for aluminium, iron and lead may
same starting-point 10 µl of the test solution. Develop be carried out simultaneously with the test for strontium.
for 16 h using a mixture of 0.3 ml of ammonia R, 5 g of If this is not the case, the reference solutions are prepared
trichloroacetic acid R, 25 ml of water R and 75 ml of such that they contain strontium at approximately the
2-propanol R. Allow the paper to dry in air. Determine the same concentration as in the test solution.
position of the inactive phosphoric acid by spraying with a Aluminium. Not more than 2 µg/ml, determined by atomic
50 g/l solution of perchloric acid R and then with a 10 g/l emission spectrometry (plasma or arc method) (2.2.22,
solution of ammonium molybdate R. Expose the paper to Method I).
hydrogen sulphide R. A blue colour develops. Determine
the position of the radioactive spot by autoradiography or Test solution. Dilute 0.2 ml of the injection to be examined
by measuring the radioactivity over the whole length of to a suitable volume with dilute nitric acid R.
the chromatogram. Not less than 95 per cent of the total Reference solutions. Prepare the reference solutions using
radioactivity of the chromatogram is found in the spot aluminium standard solution (10 ppm Al) R diluted as
corresponding to phosphoric acid. necessary with dilute nitric acid R.
Iron. Not more than 5 µg/ml, determined by atomic emission
RADIOACTIVITY spectrometry (plasma or arc method) (2.2.22, Method I).
Measure the radioactivity using suitable counting equipment Test solution. Dilute 0.2 ml of the injection to be examined
by comparison with a standardised phosphorus-32 solution to a suitable volume with dilute nitric acid R.
or by measurement in an instrument calibrated with the aid
of such a solution. Reference solutions. Prepare the reference solutions using
iron standard solution (20 ppm Fe) R diluted as necessary
with dilute nitric acid R.
01/2005:1475 Lead. Not more than 5 µg/ml, determined by atomic
emission spectrometry (plasma or arc method) (2.2.22,
STRONTIUM ( Sr) CHLORIDE
89 Method I).
Test solution. Dilute 0.2 ml of the injection to be examined
INJECTION to a suitable volume with dilute nitric acid R.
Reference solutions. Prepare the reference solutions using
Strontii (89Sr) chloridi solutio iniectabilis lead standard solution (10 ppm Pb) R diluted as necessary
with dilute nitric acid R.
DEFINITION
Strontium (89Sr) chloride injection is a sterile solution Strontium. 6.0 mg/ml to 12.5 mg/ml. Examine by atomic
of [89Sr]strontium chloride. Strontium-89 is a radioactive emission spectrometry (2.2.22, Method I).
isotope of strontium and is produced by neutron irradiation Test solution. Dilute 0.2 ml of the injection to be examined
of strontium enriched in strontium-88. The injection to a suitable volume with dilute nitric acid R.
contains not less than 90.0 per cent and not more than Reference solutions. Prepare the reference solutions using
110.0 per cent of the declared strontium-89 radioactivity at strontium standard solution (1.0 per cent Sr) R diluted as
the date stated on the label. Not more than 0.6 per cent of necessary with dilute nitric acid R.

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