Indium (111In) chloride solution
EUROPEAN PHARMACOPOEIA 5.0
Detection : spectrophotometer at 280 nm and radioactivity
detector set for iodine-125 connected in series.
Injection : loop injector.
Run time : 85 min.
Retention times :
Fraction
Description of the compound
Retention
time
(min)
1
I
High molecular mass
compound
18 - 20
2
II
Poly III albumin
23 - 24
3
III
Poly II albumin
25 - 26
4
IV
Poly I albumin
28
5
V
Human serum albumin
29 - 31
6
VI
Iodide
43 - 45
Peak
No.
IDENTIFICATION
A. Carry out the test after allowing sufficient time for
short-lived impurities such as indium-110m to decay.
Record the gamma-ray and X-ray spectrum using a
suitable instrument. The spectrum does not differ
significantly from that of a standardised indium-111
solution apart from any differences due to the presence of
indium-114m, when measured either by direct comparison
or by using an instrument calibrated with the aid of such
a solution. Standardised indium-111 and indium-114m
solutions are available from laboratories recognised by
the competent authority. The most prominent gamma
photons of indium-111 have energies of 0.171 MeV and
0.245 MeV.
B. To 100 µl of silver nitrate solution R2 add 50 µl of the
solution. A white precipitate is formed.
C. It complies with the test for pH (see Tests).
D. Examine the chromatogram obtained in the test for
radiochemical purity. The principal peak has an Rf value
of 0.5 to 0.8.
The main peak in the chromatogram obtained with the
reference solution corresponds to fraction V.
Limits :
— radioactivity in fractions II to V : minimum 80 per cent of
the total radioactivity applied to the column,
— iodine-125 in fraction VI : maximum 5 per cent of the
total radioactivity.
TESTS
pH (2.2.3). The pH of the solution is 1.0 to 2.0.
Cadmium. Not more than 0.40 µg/ml, determined by
electrothermal atomic absorption spectrometry (2.2.23,
Method I).
Test solution. Dilute 0.05 ml of the solution to be examined
to a suitable volume with a suitable concentration of
RADIOACTIVITY
hydrochloric acid R.
Measure the radioactivity using suitable equipment by
Reference solutions. Prepare the reference solutions using
comparison with a standardised iodine-125 solution or by
cadmium standard solution (0.1 per cent Cd) R, diluted
measurement with a calibrated instrument.
as necessary with the same concentration of hydrochloric
acid R as in the solution to be examined.
LABELLING
Measure the absorbance at 228.8 nm using a cadmium
The label states :
hollow-cathode lamp as source of radiation.
— the amount of albumin,
Copper. Not more than 0.15 µg/ml, determined by
— the maximum volume to be injected.
electrothermal atomic absorption spectrometry (2.2.23,
Method I).
Test solution. Dilute 0.1 ml the solution to be examined
01/2005:1227
to a suitable volume with a suitable concentration of
hydrochloric acid R.
INDIUM (111In) CHLORIDE SOLUTION Reference solutions. Prepare the reference solutions
using copper standard solution (0.1 per cent) R diluted
Indii (111In) chloridi solutio
as necessary with the same concentration of hydrochloric
acid R as the solution to be examined.
DEFINITION
Measure the absorbance at 324.8 nm using a copper
Indium (111In) chloride solution is a sterile solution of
hollow-cathode lamp as source of radiation.
indium-111 as the chloride in aqueous hydrochloric acid
containing no additives. Indium-111 is a radioactive isotope Iron. Not more than 0.60 µg/ml, determined by
of indium and may be produced by the irradiation of cadmium electrothermal atomic absorption spectrometry (2.2.23,
Method I).
with protons of suitable energy. The solution contains not
less than 90.0 per cent and not more than 110.0 per cent of Test solution. Dilute 0.1 ml of the solution to be examined
the declared indium-111 radioactivity at the date and hour
to a suitable volume with a suitable concentration of
stated on the label. Not more than 0.25 per cent of the total hydrochloric acid R.
radioactivity is due to radionuclides other than indium-111.
Reference solutions. Prepare the reference solutions
Not less than 95 per cent of the radioactivity corresponds to
using iron standard solution (0.1 per cent Fe) R diluted
indium-111 in the form of ionic indium(III). The method of
as necessary with the same concentration of hydrochloric
preparation is such that no carrier is added and the specific
acid R as the solution to be examined.
radioactivity is not less than 1.85 GBq of indium-111 per
Measure the absorbance at 248.3 nm using an iron
microgram of indium.
hollow-cathode lamp as source of radiation.
CHARACTERS
Sterility. It complies with the test for sterility
A clear, colourless solution.
prescribed in the monograph on Radiopharmaceutical
Indium-111 has a half-life of 2.8 days and emits gamma
preparations (0125). The solution may be released for use
radiation and X-rays.
before completion of the test.
828
See the information section on general monographs (cover pages)
EUROPEAN PHARMACOPOEIA 5.0
Indium (111In) oxine solution
RADIONUCLIDIC PURITY
Record the gamma-ray and X-ray spectrum using a suitable
instrument. The spectrum does not differ significantly from
that of a standardised solution of indium-111 apart from any
differences due to the presence of indium-114m.
Indium-114m. Carry out the test after allowing sufficient
time for short-lived impurities such as indium-110m to
decay. Take a volume equivalent to 30 MBq and record
the gamma-ray spectrum using a suitable detector with a
shield of lead, 6 mm thick, placed between the sample and
the detector. The response in the region corresponding
to the 0.558 MeV photon and the 0.725 MeV photon of
indium-114m does not exceed that obtained using 75 kBq
of a standardised solution of indium-114m (0.25 per cent)
measured under the same conditions, when all measurements
are calculated with reference to the date and hour of
administration. Standardised indium-111 and indium-114m
solutions are available from laboratories recognised by the
competent authority.
RADIOCHEMICAL PURITY
Examine by thin-layer chromatography (2.2.27) using silica
gel as the coating substance on a glass-fibre sheet.
Apply to the plate 5 µl of the solution to be examined.
Develop immediately over a path of 15 cm using a 9.0 g/l
solution of sodium chloride R adjusted to pH 2.3 ± 0.05
with dilute hydrochloric acid R. Allow the plate to dry
in a current of cold air. Determine the distribution of
radioactivity using a suitable detector. Indium-111 chloride
migrates with an Rf value of 0.5 to 0.8. Not less than
95 per cent of the total radioactivity of the chromatogram
corresponds to indium-111 chloride.
label. Not more than 0.25 per cent of the total radioactivity
is due to radionuclides other than indium-111. Not less than
90 per cent of the radioactivity corresponds to indium-111
complexed with oxine. The method of preparation is such
that no carrier is added and the specific radioactivity is not
less than 1.85 GBq of indium-111 per microgram of indium.
General Notices (1) apply to all monographs and other texts
829
CHARACTERS
A clear, colourless solution.
Indium-111 has a half-life of 2.8 days and emits gamma
radiation and X-rays.
IDENTIFICATION
A. Carry out the test after allowing sufficient time for
short-lived impurities such as indium-110m to decay.
Record the gamma-ray and X-ray spectrum using a
suitable instrument. The spectrum does not differ
significantly from that of a standardised indium-111
solution apart from any differences due to the presence of
indium-114m, when measured either by direct comparison
or by using an instrument calibrated with the aid of such
a solution. Standardised indium-111 and indium-114m
solutions are available from laboratories recognised by
the competent authority. The most prominent gamma
photons of indium-111 have energies of 0.171 MeV and
0.245 MeV.
B. Place 5 mg to 10 mg of magnesium oxide R in a glass
container of approximately 20 mm in internal diameter.
Add 20 µl of the solution to be examined. Examine in
ultraviolet light at 365 nm. Bright yellow fluorescence
is produced.
C. The distribution of radioactivity between the organic
RADIOACTIVITY
and aqueous phases in the test for radiochemical purity
contributes to the identification of the preparation.
Measure the radioactivity using suitable counting equipment
by comparison with a standardised indium-111 solution or
by measurement in an instrument calibrated with the aid of TESTS
such a solution.
pH (2.2.3). The pH of the solution is 6.0 to 7.5.
Sterility. It complies with the test for sterility
01/2005:1109 prescribed in the monograph on Radiopharmaceutical
preparations (0125). The solution may be released for use
before completion of the test.
INDIUM (111In) OXINE SOLUTION
RADIONUCLIDIC PURITY
Record the gamma-ray and X-ray spectrum using a suitable
Indii (111In) oxini solutio
instrument. The spectrum does not differ significantly from
that of a standardised solution of indium-111, apart from any
differences due to the presence of indium-114m.
Indium-114m. Carry out the test after allowing sufficient
time for short-lived impurities such as indium-110m to
decay. Take a volume equivalent to 30 MBq and record the
gamma-ray spectrum using a suitable detector with a shield
of lead, 6 mm thick, placed between the sample and the
detector. The response in the region corresponding to the
0.558 MeV photon and the 0.725 MeV photon of indium-114m
does not exceed that obtained using 75 kBq of a standardised
solution of indium-114m (0.25 per cent) measured under the
same conditions, when all measurements are calculated with
111
C27H18[ In]N3O3
Mr 547.2 reference to the date and hour of administration. (It should
be noted that indium (111In) oxine solution is a precursor
DEFINITION
used in the in vitro labelling of white blood cells or platelets
111
Indium ( In) oxine solution is a sterile solution of indium-111
prior to their re-injection into the patient. It is not intended
in the form of a complex with 8-hydroxyquinoline. It may
for direct administration). Standardised indium-111 and
contain suitable surface active agents and may be made
indium-114m solutions are available from laboratories
iso-tonic by the addition of sodium chloride and a suitable
recognised by the competent authority.
buffer. Indium-111 is a radioactive isotope of indium and may
RADIOCHEMICAL PURITY
be produced by the irradiation of cadmium with protons of
suitable energy. The solution contains not less than 90.0 per To a silanised separating funnel containing 3 ml of a 9 g/l
cent and not more than 110.0 per cent of the declared
solution of sodium chloride R add 100 µl of the solution
indium-111 radioactivity at the date and hour stated on the to be examined and mix. Add 6 ml of octanol R and shake