Indium In 111Capromab Pendetide Injection
»Indium In 111Capromab Pendetide Injection is a sterile,nonpyrogenic,murine monoclonal antibody,7E11-C5.3,(CYT-351),an immunoconjugate prepared by specific modification of the carbohydrate groups and covalent binding to the tripeptide linker chelator,glycyltyrosyl-(N,E-diethylenetriaminepentaacetic acid)-lysine hydrochloride that is complexed with 111In.It contains not less than 90.0percent and not more than 110.0percent of the specified amount of 111In capromab pendetide,expressed in megabexquerels (or millicuries)per mLat the time indicated in the labeling.Other chemical forms of radioactivity do not exceed 10.0percent of the total radioactivity.Immediately prior to use,the radiolabeling is performed with Indium In 111Chloride Solution in the presence of a sodium acetate buffer.It contains sodium chloride and buffering agents as stabilizers.The immuno-reactive fraction,determined by a validated method,is not less than 70percent.The monomer content is not less than 95percent determined by a validated electrophoretic mobility method.
Packaging and storage— Preserve in adequately shielded single-dose containers at controlled room temperature for not more than 8hours.
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 capromab pendetide as total MBq (or mCi)and concentration of MBq (or mCi)per mL,at the time of calibration;the expiration date and time;and the storage temperature 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 67.2hours.
Bacterial endotoxins á85ñ— The limit of endotoxin content is not more than 175/VUSP Endotoxin Units 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 5.0and 7.0.
Radiochemical purity—
Absorbent: 1-cm ×8-cm instant silica gel strip.
Test solution: a mixture of the Injection and 0.05Mpentetic acid (1:1).
Application volume: 10µL.
Developing solvent system: 0.9%sodium chloride solution.
Procedure— Proceed as directed for Thin-Layer Chromatographyunder Chromatography á621ñby ascending chromatography.Determine the distribution of radioactivity on the chromatogram by scanning with a suitable collimated radiochromatogram strip scanner,and determine the percentage of radiochemical purity of the test specimen.Not less than 90%of the In 111activity is present as a band between the RFvalues of 0and 0.1.
Other requirements— It meets the requirements for Radionuclide identificationand Radionuclidic purityunder Indium In 111Chloride Solution.It meets also the requirements under Injections á1ñ,except that the radioactive component may be distributed or dispensed prior to completion of the test for Sterility,the latter test being started on the date of manufacture.
Assay for radioactivity á821ñ— Using a suitable counting assembly (see Selection of a Counting Assembly),determine the total radioactivity,in MBq (or µCi),of the unshielded Injection by use of a calibrated system.
Auxiliary Information— Staff Liaison:Andrzej Wilk,Ph.D.,Senior Scientific Associate
Expert Committee:(RMI)Radiopharmaceuticals and Medical Imaging Agents
USP28–NF23Page 1008
Phone Number:1-301-816-8305
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