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1
: the time and date of calibration; the amount of 99mTc as labeled nofetumomab merpentan expressed in 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 the radioactive half-life of 99mTc is 6.0 hours 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 6 hours following constitution.
85:
not more than 175/V USP Endotoxin Unit per mL of the Injection, in which V is the maximum recommended total dose, in mL, at the expiration date or time.
791:
between 7.0 and 8.0.
621) until the solvent front has moved 8 cm 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 RF values of 0.4 and 0.7; and not less than 85% of the total radioactivity is found as 99mTc at the origin.
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.
821—
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.