Indium In 111Satumomab Pendetide Injection
»Indium In 111Satumomab Pendetide Injection is a sterile,nonpyrogenic,virus-free preparation of monoclonal antibody B72.3that is labeled with 111In.Satumomab pendetide is prepared by site-specific conjugation of the linker-chelator,glycyl-tyrosyl-(N,E-diethylene triamine pentaacetic acid)-lysine hydrochloride to the oxidized oligosaccharide component of the monoclonal antibody B72.3.Satumomab pendetide is radiolabeled by the addition of a sterile,nonpyrogenic solution of a buffered Indium In 111Chloride solution.[NOTE—Other chemical forms of indium are not to be used in the radiolabeling.]It contains not less than 90.0percent and not more than 110.0percent of the labeled amount of 111In as labeled satumomab pendetide expressed in megabecquerels (or in millicuries)per mLat the time indicated in the labeling.Other chemical forms of radioactivity do not exceed 10.0percent of the total radioactivity.It may contain buffers and stabilizers.The immunoreactive fraction,as determined by a validated method,is not less than 60percent.
Packaging and storage— Preserve in adequately shielded single-dose containers,at controlled room temperature.
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 111In as labeled satumomab pendetide expressed as total megabecquerels (or millicuries)and concentration as megabecquerels (or millicuries)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 111In is 67.3hours.
Bacterial endotoxins á85ñ— It contains not more than 175/VUSP Endotoxin Units per mLof the Injection,when compared with USP Endotoxin RS,in which Vis the maximum recommended total dose,in mL,at the expiration date or time.
pHá791ñ: between 5.5and 6.5.
Radiochemical purity— Mix equal parts of Injection with 0.05Mdiethylenetriamine pentaacetic acid in a clean glass vial.Apply a drop of this solution 1cm from the bottom of a 1-cm ×8-cm instant thin-layer chromatographic silica gel strip.Allow the spot to air-dry,and develop the strip by ascending chromatography,using 0.9%sodium chloride solution as the solvent.Allow the solvent front to migrate 6cm from the origin.Remove the strip from the solvent,and air-dry.Determine the distribution of radioactivity on the chromatogram by scanning with a suitable collimated radiochromatogram strip scanner,or cut the strip 1.6cm from the bottom and determine the radioactivity of each piece in a suitable detector.Not less than 90%of the In-111activity must be present as a band between RF=0and 0.1.
Other requirements— It meets the requirements of the tests for Radionuclide identificationand Radionuclidic purityunder Indium In 111Chloride Solution.It meets also the requirements under Injections á1ñ,except that it may be distributed or dispensed prior to 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 radioactivity— Using a suitable counting assembly (see Selection of a Counting Assemblyunder Radioactivity á821ñ),determine the radioactivity,in MBq (or µCi)per mL,of the 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 1012
Phone Number:1-301-816-8305