Indium In 111Chloride Solution

Indium Chloride (111InCl3).
Indium (111In)trichloride [10025-82-8].
»Indium In 111Chloride Solution is a sterile,nonpyrogenic solution of radioactive indium (111In)in dilute hydrochloric acid suitable for the radiolabeling of proteins such as monoclonal antibodies,peptides,or small biologically active organic molecules.The concentration of acid and 111In per mLof Indium In 111Chloride Solution may require adjustment for the specific antibody or peptide being labeled.It contains not less than 90.0percent and not more than 110.0percent of the labeled amount of 111In expressed as megabecquerels (or millicuries)per mLat the time indicated in the labeling.Other chemical forms of radioactivity do not exceed 10.0percent of the total radioactivity.[NOTE—Indium In 111Chloride Solution is generally recommended for use with specific antibodies or peptides.Consult the product labeling for recommendations and applications for radiolabeling.]
Specific activity: not less than 1.85gigabecquerels (50millicuries)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 Labelingunder Injections á1ñ: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 67.3hours.
Identification— Add 1drop of it to 2drops of 0.1Msilver nitrate in a glass test tube:a white precipitate is formed (presence of chloride).
Bacterial endotoxins á85ñ— It contains not more than 175/VUSP Endotoxin Unit per mL,in which Vis the maximum recommended total dose,in mL,at the expiration date or time.
Acidity— Pipet 20µLof the Solution into a plastic tube containing 1drop of bromocresol green,and titrate with 0.0025Nsodium carbonate to a blue endpoint.Calculate the acidity of the Solution by the formula:
0.0025VT/20,
in which VTis the volume of titrant consumed:the molarity of the Solution is between 0.035and 0.045.
Radionuclide identification á821ñ— Its gamma-ray spectrum is identical to that of a specimen of 111In that exhibits major photopeaks having energies of 0.171and 0.245MeV.
Radionuclidic purity á821ñ— Using a suitable counting assembly (see Selection of a Counting Assemblyunder Radioactivity á821ñ),determine the radioactivity of each radionuclidic impurity,in kBq per MBq (µCi per mCi)of 111In,in the Solution by use of a calibrated system as directed under Radioactivity á821ñ.
INDIUM110m— The limit of 110mIn is 3kBq per Mbq (or 3µCi 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 0.66and 0.91MeV.110mIn decays with a half-life of 4.9hours.
INDIUM114m— The limit of 114mIn is 3kBq per MBq (or 3µCi 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 3kBq per MBq (or 3µCi per mCi)of 111In.The presence of 65Zn in the Solution is demonstrated by a characteristic gamma-ray spectrum with a prominent photopeak at 1.116MeV.65Zn decays with a radioactive half-life of 243.9days.
Radiochemical purity— Dispense about 50µLof Solution into 1mLof 0.04Mhydrochloric acid,taking care to use polypropylene tips prewashed in 0.04Mhydrochloric acid for all dispensings.Draw a line approximately 10cm from one end of a Whatman No.1paper strip (5×25cm).Using dispensers with polypropylene tips prewashed in 0.04Mhydrochloric acid,spot 10µLof 0.5Nsodium carbonate at the start position followed by 2µLof the test specimen.Allow the strip to air-dry,place in a chromatography jar,and elute downwards using 1Msodium 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 á851ñ),using a graphite furnace to volatilize the copper,as directed by the manufacturer of the instrument used,and measuring the absorbance at 324.8nm against a standard.
Nickel— Determine the nickel,in µg per mL,in the Solution by atomic absorption spectrometry (see Spectrophotometry and Light-scattering á851ñ),using a graphite furnace to volatilize the nickel,as directed by the manufacturer of the instrument used,and measuring the absorbance at 232.0nm against a standard.
Cadmium— Determine the cadmium,in µg per mL,in the Solution by atomic absorption spectrometry (see Spectrophotometry and Light-scattering á851ñ),using a graphite furnace to volatilize the cadmium,as directed by the manufacturer of the instrument used,and measuring the absorbance at 228.8nm against a standard.
Lead— Determine the lead,in µg per mL,in the Solution by atomic absorption spectrometry (see Spectrophotometry and Light-scattering á851ñ),using a graphite furnace to volatilize the lead,as directed by the manufacturer of the instrument used,and measuring the absorbance at 217.0nm against a standard.
Mercury— Determine the mercury,in µg per mL,in the Solution by atomic absorption spectrometry (see Spectrophotometry and Light-scattering á851ñ),using a graphite furnace to volatilize the mercury,as directed by the manufacturer of the instrument used,and measuring the absorbance at 253.7nm against a standard.
Iron— Determine the iron,in µg per mL,in the Solution by atomic absorption spectrometry (see Spectrophotometry and Light-scattering á851ñ),using a graphite furnace to volatilize the iron,as directed by the manufacturer of the instrument used,and measuring the absorbance at 248.3nm against a standard.
Zinc— Prepare a zinc stock solution in dilute hydrochloric acid (1in 100)having a concentration of 1µg of zinc per mL.Pipet 10mLof the zinc stock solution into a 100-mLvolumetric flask,dilute with water to volume,and mix to obtain a solution having a concentration of 0.1µg of zinc per mL(Standard solution A).Pipet 20mLof the zinc stock solution into a 100-mLvolumetric flask,dilute with water to volume,and mix to obtain a solution having a concentration of 0.2µg of zinc per mL(Standard solution B).Pipet 0.1mLof Indium Chloride In 111Solution into a 10-mLvolumetric flask,dilute with water to volume,and mix to obtain the test solution.Determine the absorbances of the Standard solutionsand the test solution at the zinc emission line at 213.9nm with an atomic absorption spectrophotometer (see Spectrophotometry and Light-scattering á851ñ)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 1.0µg per mL.
Other requirements— It meets the requirements under Injections á1ñ,except that the Solution may be distributed or dispensed prior to completion of the test for Sterility á71ñ,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.
Assay for radioactivity á821ñ— Using a suitable counting assembly (see Selection of a Counting Assembly),determine the radioactivity,in MBq (or in microcuries or millicuries)per mL,of the Solution,by the use of a calibrated system.
Auxiliary Information— Staff Liaison:Andrzej Wilk,Ph.D.,Senior Scientific Associate
Expert Committee:(RMI)Radiopharmaceuticals and Medical Imaging Agents
USP28–NF23Page 1008
Phone Number:1-301-816-8305