Iodinated I131Albumin Injection

Albumin labeled with iodine-131.
»Iodinated I131Albumin Injection is a sterile,buffered,isotonic solution containing normal human albumin adjusted to provide not more than 37MBq (1mCi)of radioactivity per mL.It is derived by mild iodination of normal human albumin with the use of radioactive iodine (131I)to introduce not more than one gram-atom of iodine for each gram-molecule (60,000g)of albumin.
Iodinated I131Albumin Injection contains not less than 95.0percent and not more than 105.0percent of the labeled amount of 131Ias iodinated albumin,expressed in megabecquerels (microcuries or in millicuries)per mLat the time indicated in the labeling.Other forms of radioactivity do not exceed 3percent of the total radioactivity.Its production and distribution are subject to federal regulations (see Biologics á1041ñand Radioactivity á821ñ).
Labeling— Label it to include the following,in addition to the information specified for Labelingunder Injections á1ñ:the date of calibration;the amount of 131Ias iodinated albumin,expressed as total megabecquerels (millicuries or microcuries),and concentration 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.
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.
Other requirements— It meets the requirements for Packaging and storage,Bacterial endotoxins,pH,Radiochemical purity,and Assay for radioactivityunder Iodinated I125Albumin Injection.It meets also the requirements under Biologics á1041ñ,and the requirements under Injections á1ñ,except that it is not subject to the recommendation on Volume in Container.It meets all other applicable requirements of the FDA.
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