Packaging and storage— Preserve in single-dose containers.

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 pentetic acid complex expressed as total megabecquerels (millicuries or microcuries)and concentration as megabecquerels (microcuries or millicuries)per mLon the date and time of calibration;the expiration date;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 2.83days.

USP Reference standards á11ñ— USP Endotoxin RS.

Bacterial endotoxins á85ñ— It contains not more than 14/VUSP Endotoxin Unit per mLof the Injection,when compared with the USP Endotoxin RS,in which Vis the maximum recommended total dose,in mL,at the expiration date or time.

pHá791ñ: between 7.0and 8.0.

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 0.173and 0.247MeV.

Radiochemical purity— Place 2µLto 5µLof Injection about 17mm from one end of a 65-×97-mm piece of silica gel-impregnated glass microfiber sheet (see under Reagentsin the section Reagents,Indicators,and Solutions)(see also Chromatography á621ñ),and allow to dry.Repeat applications may be made to obtain a suitable count rate.Develop the chromatogram over a suitable period of time by ascending chromatography,using dilute methanol (8.5in 10),and dry in an oven at 105±5for 5minutes.Determine the radioactivity distribution by scanning the chromatogram with a suitable collimated radiation detector.The radioactivity of the indium pentetic acid complex band is not less than 90.0%of the total radioactivity,and the RFvalue is between 0.8and 1.0.

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 Injection by use of a calibrated system as directed under Radioactivity á821ñ.

Other requirements— It meets the requirements under Injections á1ñ,except that the Injection may be distributed or dispensed prior to the completion of the test for Sterility,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— Using a suitable counting assembly (see Selection of a Counting Assemblyunder Radioactivity á821ñ),determine the radioactivity,in MBq per mL,of Injection by use of a calibrated system as directed under Radioactivity á821ñ.

Expert Committee:(RMI)Radiopharmaceuticals and Medical Imaging Agents

USP28–NF23Page 1011

Phone Number:1-301-816-8305