Packaging and storage— Preserve in single-dose containers that are totally filled,so that any air present occupies not more than 0.5%of the total volume of the container.Store at a temperature between 2and 8.If there is free space above the solution,a significant amount of the xenon 133is present in the gaseous phase.Glass containers may darken under the effects of radiation.

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 xenon 133expressed as total megabecquerels (microcuries or millicuries),and concentration as megabecquerels (microcuries or millicuries),per mLat the time of calibration;the expiration date;the name and amount of any added bacteriostatic agent;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 133Xe is 5.24days.

USP Reference standards á11ñ— USP Endotoxin RS.

Radionuclide identification (see Radioactivity á821ñ)— Its gamma-ray and X-ray spectra are identical to those of a known specimen of xenon 133that exhibits two major photopeaks having energies of 0.081MeVand 0.031MeV(X-ray peak).

Bacterial endotoxins á85ñ— It contains not more than 175/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 4.5and 8.0.

Radionuclidic purity— Using a suitable counting assembly (see Selection of a Counting Assemblyunder Radioactivity á821ñ),determine the radioactivity of Xe 133in the Injection by use of a calibrated system as directed under Radioactivity á821ñ.The radioactivity exhibited at 0.081MeVand 0.031MeVis not less than 95.0%of the total radioactivity of the specimen.

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 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 (mCi)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 2038

Phone Number:1-301-816-8305