Iodinated I125Albumin Injection

Albumin labeled with iodine-125.
»Iodinated I125Albumin Injection is a sterile,buffered,isotonic solution containing normal human albumin adjusted to provide not more than 37megabecquerels (1millicurie)of radioactivity per mL.It is derived by mild iodination of normal human albumin with the use of radioactive iodine (125I)to introduce not more than one gram-atom of iodine for each gram-molecule (60,000g)of albumin.
Iodinated I125Albumin Injection contains not less than 95.0percent and not more than 105.0percent of the labeled amount of 125Ias 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).
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 date of calibration;the amount of 125Ias iodinated albumin,expressed as total megabecquerels (microcuries or millicuries),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 125Iis 60days.
Radionuclide identification (see Radioactivity á821ñ)— Its gamma-ray spectrum is identical to that of a specimen of 125Iof known purity that exhibits a major photopeak having an energy of 0.0355MeV.
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,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 dilute methanol (7in 10),and air-dry.Determine the radioactivity distribution by scanning the chromatogram with a suitable collimated radiation detector:not less than 97.0%of the total activity is found as albumin (at the point of application).
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 all other applicable requirements of the FDA.
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 1034
Phone Number:1-301-816-8305