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 IgG monoclonal antibody Immu-4, suitable for intravenous administration that is labeled with 99mTc. It contains not less than 90.0 percent and not more than 110.0 percent of the labeled amount of 99mTc as an arcitumomab complex, expressed in MBq (or mCi) per mL at the time indicated in the labeling. Other chemical forms of radioactivity do not exceed 10.0 percent 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 90 percent as determined by size-exclusion HPLC.
Packaging and storage— Preserve in single-dose Containers for Injections that are adequately shielded as described under Injections1, and store at controlled room temperature.
Labeling— Label it to include the following, in addition to the information specified for Labeling under Injections 1: 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 6.0 hours. The labeling also states that it should be used within 4 hours following constitution.
USP Reference standards 11
USP Endotoxin RS
Bacterial endotoxins 85 The limit of endotoxin content is not more than 175/V USP Endotoxin Unit per mL of the Injection, when compared with the USP Endotoxin RS, in which V is the maximum recommended total dose, in mL, at the expiration date and time.
pH 791: between 5.0 and 7.0.
Radiochemical purity— To determine the amount of free technetium, apply 1 µL of the Injection about 2.7 cm from the bottom of a 1-cm × 9-cm instant thin-layer chromatographic silica gel strip (see Chromatography 621). Immediately develop the chromatogram over a period of 4 minutes 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 identification and Radionuclidic purity under Sodium Pertechnetate Tc 99m Injection. It meets also the requirements under Injections 1, 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 821 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.
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Monograph Ravi Ravichandran, Ph.D.
Principal Scientific Liaison
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85 Radhakrishna S Tirumalai, Ph.D.
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USP35–NF30 Page 4760
Pharmacopeial Forum: Volume No. 27(2) Page 2202