Iodinated I131Albumin Aggregated Injection

Albumin labeled with iodine-131.
»Iodinated I131Albumin Aggregated Injection is a sterile aqueous suspension of Albumin Human that has been iodinated with 131Iand denatured to produce aggregates of controlled particle size.Each mLof the suspension contains not less than 300µg and not more than 3.0mg of aggregated albumin with a specific activity of not less than 7.4megabecquerels (200microcuries)per mg and not more than 44.4megabecquerels (1.2millicuries)per mg of aggregated albumin.Iodinated I131Albumin Aggregated Injection contains not less than 95.0percent and not more than 105.0percent of the labeled amount of 131I,as aggregated albumin,expressed in megabecquerels (microcuries)per mLor megabecquerels (millicuries)per mLat the time indicated in the labeling.Other chemical forms of radioactivity do not exceed 6percent of the total radioactivity.Its production and distribution are subject to federal regulations (see Biologics á1041ñand Radioactivity á821ñ).
Packaging and storage— Preserve in single-dose or in multiple-dose containers,at a temperature between 2and 8.
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 aggregated albumin expressed as total megabecquerels (microcuries or millicuries)and as aggregated albumin in mg 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;in addition,the labeling states that it is not to be used if clumping of the albumin is observed and directs that the container be agitated before the contents are withdrawn into a syringe.
Radionuclide identification— 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.
pHá791ñ: between 5.0and 6.0.
Other requirements— It meets the requirements under Biologics á1041ñand under Injections á1ñ,except that it is not subject to the recommendation on Volume in Container.It meets also the requirements for Particle size,Bacterial endotoxins,and Radiochemical purityunder Technetium Tc 99m Albumin Aggregated Injection,except that in the test for Radiochemical purity,not more than 6%of the radioactivity is found in the supernatant following centrifugation.
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.
Auxiliary Information— Staff Liaison:Andrzej Wilk,Ph.D.,Senior Scientific Associate
Expert Committee:(RMI)Radiopharmaceuticals and Medical Imaging Agents
USP28–NF23Page 1035
Phone Number:1-301-816-8305