C20H2Cl4131I4Na2O5

Spiro[isobenzofuran-1(3H),9¢-[9H]-xanthene]-3-one,4,5,6,7-tetrachloro-3¢,6¢-dihydroxy-2¢,4¢,5¢,7¢-tetraiodo-,disodium salt,labeled with iodine-131.
4,5,6,7-Tetrachloro-2¢,4¢,5¢,7¢-tetraiodofluorescein disodium salt-131I [24916-55-0;50291-21-9;15251-14-6].

Packaging and storage— Preserve in single-dose or in multiple-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 131Ias rose bengal sodium expressed as total megabecquerels (microcuries or millicuries)and as megabecquerels (microcuries or millicuries)per mLon the date 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 131Iis 8.08days.

USP Reference standards á11ñ— USP Endotoxin RS.

Radionuclide identification (see Radioactivity á821ñ)— Its gamma-ray spectrum is identical to that of a specimen of 131Iof known purity that exhibits a major photopeak having an energy of 0.364MeV.

Bacterial endotoxins á85ñ— The limit of endotoxin content is 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.

Radiochemical purity— Place a measured volume of a solution containing 100mg of potassium iodide,200mg of potassium iodate,and 1g of sodium bicarbonate in each 100mLabout 25mm from one end of a 25-×300-mm strip of chromatographic paper (see Chromatography á621ñ),and allow to dry.To the same area add a similar volume of appropriately diluted Injection such that it provides a count rate of about 20,000counts per minute,and allow to dry.Develop the chromatogram over a period of about 2hours by ascending chromatography,using 1Nacetic acid.Dry the chromatogram in air,and determine the radioactivity distribution by scanning the chromatogram with a suitable collimated radiation detector.The radioactivity under the rose bengal band is not less than 90.0%of the total radioactivity.The rose bengal band is at the point of application.

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 rose bengal sodium— Determine the absorbance of Injection,appropriately diluted,in a 1-cm cell at 550nm,with a suitable spectrophotometer,using a sodium bicarbonate solution adjusted to a pHof 8.0as the blank.Calculate the quantity,in mg,of rose bengal sodium per mLof the Injection taken by the formula: in which Dis the dilution factor,AUis the absorbance of the solution,and ASis the absorbance,similarly determined,of a solution of rose bengal sodium adjusted to a pHof 8.0by the addition of sodium bicarbonate and containing 4µg of rose bengal sodium per mL.

Assay for radioactivity— Using a suitable counting assembly (see Selection of a Counting Assemblyunder Radioactivity á821ñ),determine the radioactivity,in MBq (µCi)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 1036

Phone Number:1-301-816-8305