Specific activity:
not less than 1.85 gigabecquerels (50 millicuries) per µg of indium at the date and time of calibration.
Packaging and storage—
Preserve in single-unit containers at controlled room temperature.
Labeling—
Label it to include the following, in addition to the information specified for
Labeling under
Injections 
1
: the time and date of calibration; the amount of
111In as labeled chloride expressed as total megabecquerels (or millicuries) and the concentration as megabecquerels per mL (or as millicuries per mL) on the date and time of calibration; the expiration date; the statement, “Not for direct administration. Use only as an ingredient for radiolabeling;” and the statement, “Caution—Radioactive Material.” The labeling indicates that in making dosage calculations, correction is to be made for radioactive decay, and also indicates that the radioactive half-life of
111In is 67.3 hours.
Identification—
Add 1 drop of it to 2 drops of 0.1 M silver nitrate in a glass test tube: a white precipitate is formed (presence of chloride).
Bacterial endotoxins 85—
It contains not more than 175/
V USP Endotoxin Unit per mL, in which
V is the maximum recommended total dose, in mL, at the expiration date or time.
Acidity—
Pipet 20 µL of the Solution into a plastic tube containing 1 drop of bromocresol green, and titrate with 0.0025 N sodium carbonate to a blue endpoint. Calculate the acidity of the Solution by the formula:
0.0025VT / 20,
in which
VT is the volume of titrant consumed: the molarity of the Solution is between 0.035 and 0.045.
Radionuclide identification 821—
Its gamma-ray spectrum is identical to that of a specimen of
111In that exhibits major photopeaks having energies of 0.171 and 0.245 MeV.
Radionuclidic purity 821—
Using a suitable counting assembly (see
Selection of a Counting Assembly under
Radioactivity 821), determine the radioactivity of each radionuclidic impurity, in kBq per MBq (µCi per mCi) of
111 In, in the Solution by use of a calibrated system as directed under
Radioactivity 821.
INDIUM 110m—
The limit of 110mIn is 3 kBq per Mbq (or 3 µCi per mCi) of 111mIn. The presence of 110mIn in the Solution is demonstrated by a characteristic gamma-ray spectrum with prominent photopeaks having energies of 0.66 and 0.91 MeV. 110mIn decays with a half-life of 4.9 hours.
INDIUM 114m—
The limit of 114mIn is 3 kBq per MBq (or 3 µCi per mCi) of 111In. 114mIn is quantified by counting the beta emissions of ground state 114In with a beta-liquid scintillation counter having a high-energy channel set to discriminate against all counts arising from 111In.
ZINC
65—The limit of 65Zn is 3 kBq per MBq (or 3 µCi per mCi) of 111In. The presence of 65Zn in the Solution is demonstrated by a characteristic gamma-ray spectrum with a prominent photopeak at 1.116 MeV. 65Zn decays with a radioactive half-life of 243.9 days.
Radiochemical purity—
Dispense about 50 µL of Solution into 1 mL of 0.04 M hydrochloric acid, taking care to use polypropylene tips prewashed in 0.04 M hydrochloric acid for all dispensings. Draw a line approximately 10 cm from one end of a Whatman No. 1 paper strip (5 × 25 cm). Using dispensers with polypropylene tips prewashed in 0.04 M hydrochloric acid, spot 10 µL of 0.5 N sodium carbonate at the start position followed by 2 µL of the test specimen. Allow the strip to air-dry, place in a chromatography jar, and elute downwards using 1 M sodium chloride as the eluent. The indium chloride will remain at the origin. After allowing the strip to air-dry, interpret the chromatogram using an appropriate scanner, and determine the percentage of radiochemical purity of the test specimen. Not less than 95% indium is present as ionic In.
Chemical purity—
Copper—
Determine the copper, in µg per mL, in the Solution by atomic absorption spectrometry (see
Spectrophotometry and Light-scattering 851), using a graphite furnace to volatilize the copper, as directed by the manufacturer of the instrument used, and measuring the absorbance at 324.8 nm against a standard.
Nickel—
Determine the nickel, in µg per mL, in the Solution by atomic absorption spectrometry (see
Spectrophotometry and Light-scattering 851), using a graphite furnace to volatilize the nickel, as directed by the manufacturer of the instrument used, and measuring the absorbance at 232.0 nm against a standard.
Cadmium—
Determine the cadmium, in µg per mL, in the Solution by atomic absorption spectrometry (see
Spectrophotometry and Light-scattering 851), using a graphite furnace to volatilize the cadmium, as directed by the manufacturer of the instrument used, and measuring the absorbance at 228.8 nm against a standard.
Lead—
Determine the lead, in µg per mL, in the Solution by atomic absorption spectrometry (see
Spectrophotometry and Light-scattering 851), using a graphite furnace to volatilize the lead, as directed by the manufacturer of the instrument used, and measuring the absorbance at 217.0 nm against a standard.
Mercury—
Determine the mercury, in µg per mL, in the Solution by atomic absorption spectrometry (see
Spectrophotometry and Light-scattering 851), using a graphite furnace to volatilize the mercury, as directed by the manufacturer of the instrument used, and measuring the absorbance at 253.7 nm against a standard.
Iron—
Determine the iron, in µg per mL, in the Solution by atomic absorption spectrometry (see
Spectrophotometry and Light-scattering 851), using a graphite furnace to volatilize the iron, as directed by the manufacturer of the instrument used, and measuring the absorbance at 248.3 nm against a standard.
Zinc—
Prepare a zinc stock solution in dilute hydrochloric acid (1 in 100) having a concentration of 1 µg of zinc per mL. Pipet 10 mL of the zinc stock solution into a 100-mL volumetric flask, dilute with water to volume, and mix to obtain a solution having a concentration of 0.1 µg of zinc per mL (
Standard solution A). Pipet 20 mL of the zinc stock solution into a 100-mL volumetric flask, dilute with water to volume, and mix to obtain a solution having a concentration of 0.2 µg of zinc per mL (
Standard solution B). Pipet 0.1 mL of Indium Chloride In 111 Solution into a 10-mL volumetric flask, dilute with water to volume, and mix to obtain the test solution. Determine the absorbances of the
Standard solutions and the test solution at the zinc emission line at 213.9 nm with an atomic absorption spectrophotometer (see
Spectrophotometry and Light-scattering 851) equipped with a zinc hollow-cathode lamp and an air–acetylene flame, using water as the blank. Determine the quantity of zinc, in µg per mL, in the Solution.
The composite total metal ion content is not greater than 1.0 µg per mL.
Other requirements—
It meets the requirements under
Injections 1, except that the Solution may be distributed or dispensed prior to completion of the test for
Sterility 71, the latter test being started on the day of final manufacture, and except that it is not subject to the recommendation on
Volume in Container.
