Packaging and storage— Preserve in single-dose or in multiple-dose containers that are adequately shielded.

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 125Ias iothalamate sodium expressed as total megabecquerels (microcuries or millicuries equivalent)per mLat the 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 125Iis 60days.

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 7.0and 8.5.

Radionuclide identification (see Radioactivity á821ñ)— Its gamma-ray spectrum is identical to that of a specimen of 125Iof known purity that exhibits a major photoelectric peak having an energy of 0.035MeV.

Radiochemical purity— Place a measured volume of Injection,diluted with a suitable diluent so that it provides a count rate of about 20,000counts per minute,about 25mm from one end of a 25-×300-mm strip of chromatographic paper (see Chromatography á621ñ),and allow to dry.Develop the chromatogram over a period of about 4hours by ascending chromatography,using methanol and ammonium hydroxide (100:1.5)adjusted with 2Nsulfuric acid to a pHof 3to 6,and air-dry.Determine the radioactivity distribution with a suitable collimated radiation detector.The radioactivity under the free radioiodide peak is not more than 2%of the total area of all peaks:not less than 98%of the total activity is found at the point of application (as iothalamate sodium).

Other requirements— It meets the requirements under Injections á1ñ,except that it is not subject to the recommendation in Volume in Container.

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

Expert Committee:(RMI)Radiopharmaceuticals and Medical Imaging Agents

USP28–NF23Page 1034

Phone Number:1-301-816-8305