Specific activity: not less than 1.85GBq (50millicuries)per µg of indium.

Packaging and storage— Preserve in single-unit containers at a temperature between 15and 25.

Labeling— Label it to contain the following,in addition to the information specified for Labelingunder Injections á1ñ:the time and date of calibration;the amount of 111In as the 8-hydroxyquinoline complex expressed as total megabecquerels (millicuries)and concentration as megabecquerels (millicuries)per mLon the date and time of calibration;the expiration date;the statement “Not for direct administration.Use only for radiolabeling of leukocytes in vitro.Administer radiolabeled cells subsequently by intravenous injection,”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 67.9hours.

Pyrogen— It meets the requirements of the Pyrogen Test á151ñ.

pHá791ñ: between 6.5and 7.5.

Radionuclide identification (see Radioactivity 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.

Radiochemical purity— Place a suitable volume,about 100µL,of Solution,dilute with 3mLof 0.9percent sodium chloride solution in a separator,and extract with 6mLof n-octanol by vigorous shaking.Allow the phases to separate and then drain the lower,aqueous layer into a suitable stoppered counting tube.Drain the residual,organic layer into a similar counting tube.Rinse the separator with 1mLof n-octanol,and drain this rinse into the counting tube containing the organic layer.Rinse the separator with 5mLof 2Nhydrochloric acid,and drain this rinse into a third counting tube.Insert the stopper and measure the radioactivity in each of the three tubes in a suitable gamma counter or ionization chamber calibrated for 111In.The radiochemical purity is calculated by the formula: where Ais the radioactivity measured in the organic layer and Bis the sum of the radioactivity measured in the organic,aqueous,and acid solutions.The radioactivity of the 8-hydroxyquinoline complex is not less than 90.0%of the total radioactivity and is found in the organic layer.

Radionuclidic purity— 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.

Assay for radioactivity— Using a suitable counting assembly (see Selection of a Counting Assemblyunder Radioactivity á821ñ),determine the radioactivity,in MBq (mCi)per mL,of Solution by the use of a calibrated system as directed under Radioactivity á821ñ.

Expert Committee:(RMI)Radiopharmaceuticals and Medical Imaging Agents

USP28–NF23Page 1010

Phone Number:1-301-816-8305