Technetium Tc 99m Nofetumomab Merpentan Injection
»Technetium Tc 99m Nofetumomab Merpentan Injection is a sterile,nonpyrogenic preparation of the Fab fragment of IgG2b murine monoclonal antibody NR-LU-10that is labeled with 99mTc and is suitable for intravenous administration.It contains not less than 90.0percent and not more than 110.0percent of the labeled amount of 99mTc as the nofetumomab complex,expressed in megabecquerels (or millicuries)per mLat the time indicated in the labeling.It may contain reducing agents,buffers,and stabilizers.It contains no antimicrobial agents.Other chemical forms of radioactivity do not exceed 10percent of the total radioactivity.The immunoreactive fraction,as determined by a validated method,is not less than 85percent.
Caution—Components of the commercial kit that are used to prepare the Injection are not to be administered directly to the patient.
Packaging and storage— Preserve in single-dose containers.
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 99mTc as labeled nofetumomab merpentan expressed in MBq (or mCi)per mLat the time of calibration;the expiration date and time;the storage temperature;and the statement “Caution—Radioactive Material”.The labeling indicates that the radioactive half-life of 99mTc is 6.0hours and that,in making dosage calculations,correction is to be made for radioactive decay.The labeling also states that the Injection is to be used within 6hours following constitution.
Bacterial endotoxins á85ñ: not more than 175/VUSP Endotoxin Unit per mLof the Injection,in which Vis the maximum recommended total dose,in mL,at the expiration date or time.
pHá791ñ: between 7.0and 8.0.
Radiochemical purity—
Adsorbent: 1-×10-cm instant silica gel strip.
Test solution— Use the Injection.
Application volume: 2to 5µL.
Developing solvent system: 0.73Ntrichloroacetic acid.
Procedure— Apply the Test solutionabout 1.2cm from the bottom of the silica gel strip.Immediately develop the chromatogram by ascending chromatography (see Chromatography á621ñ)until the solvent front has moved 8cm from the origin.Allow the chromatogram to air-dry.Determine the distribution of radioactivity on the chromatogram by scanning with a suitable collimated radiation detector.Technetium Tc 99m nofetumomab merpentan remains at the origin,and nonprotein bound Tc 99m labeled material travels with the solvent front.Not more than 5.0%of the total radioactivity is present as a band between RFvalues of 0.4and 0.7;and not less than 85%of the total radioactivity is found as 99mTc at the origin.
Other requirements— It meets the requirements for Radionuclide identificationand Radionuclidic purityunder Sodium Pertechnetate Tc 99m Injection.It also meets 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 date of manufacture.
Assay for radioactivity á821ñ— Using a suitable counting assembly (see Selection of a Counting Assembly),determine the radioactivity,in MBq (or µCi)per mL,of 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 1859
Phone Number:1-301-816-8305