Packaging and storage
Preserve in single-dose containers.
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 99m
Tc 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 CautionRadioactive Material. The labeling indicates that the radioactive half-life of 99m
Tc 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.
Bacterial endotoxins 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.
1- × 10-cm instant silica gel strip.
Use the Injection.
2 to 5 µL.
Developing solvent system:
0.73 N trichloroacetic acid.
Apply the Test solution
about 1.2 cm from the bottom of the silica gel strip. Immediately develop the chromatogram by ascending chromatography (see Chromatography 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 99m
Tc at the origin.
It meets the requirements for Radionuclide identification
and Radionuclidic purity
under Sodium Pertechnetate Tc 99m Injection
. It also meets 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 µCi) per mL, of Injection by use of a calibrated system.