Technetium Tc 99m Arcitumomab Injection
»Technetium Tc 99m Arcitumomab Injection is a sterile,nonpyrogenic preparation of the 50,000-dalton Fab¢fragment generated from the murine IgGmonoclonal antibody Immu-4,suitable for intravenous administration that is labeled with 99mTc.It contains not less than 90.0percent and not more than 110.0percent of the labeled amount of 99mTc as an arcitumomab complex,expressed in MBq (or mCi)per mLat the time indicated in the labeling.Other chemical forms of radioactivity do not exceed 10.0percent of the total radioactivity.The immunoreactive fraction determined by a validated method is not less than 75%.The Fab¢fragment content is not less than 90percent as determined by size-exclusion HPLC.
Packaging and storage— Preserve in single-dose Containers for Injectionsthat are adequately shielded as described under Injectionsá1ñ,and store 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 99mTc as labeled arcitumomab expressed as total MBq (or mCi)per mL,at the time of calibration;the expiration date and time;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 99mTc is 6.0hours.The labeling also states that it should be used within 4hours following constitution.
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 and time.
pHá791ñ: between 5.0and 7.0.
Radiochemical purity— To determine the amount of free technetium,apply 1µLof the Injection about 2.7cm from the bottom of a 1-cm ×9-cm instant thin-layer chromatographic silica gel strip (see Chromatography á621ñ).Immediately develop the chromatogram over a period of 4minutes by ascending chromatography using acetone as the solvent.Allow the chromatogram to air-dry.Determine the radioactivity distribution of the chromatogram by scanning with a suitable radiation detector:not more than 5.0%of the total radioactivity is found at the solvent front as unbound pertechnetate.
Other requirements— It meets the requirements for Radionuclide identificationand Radionuclidic purityunder Sodium Pertechnetate Tc 99m Injection.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 date of manufacture.
Assay for radioactivity á821ñ— Using a suitable counting assembly (see Selection of a Counting Assembly),determine the radioactivity,in MBq (or mCi)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 1852
Pharmacopeial Forum:Volume No.27(2)Page 2202
Phone Number:1-301-816-8305