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1
: the time and date of calibration; the amount of 111In as labeled pentetic acid complex expressed as total megabecquerels (millicuries or microcuries) and concentration as megabecquerels (microcuries or millicuries) per mL on the date and time of calibration; the expiration date; 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 111In is 2.83 days.
85—
It contains not more than 14/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 or time.
791:
between 7.0 and 8.0.
821)—
Its gamma-ray spectrum is identical to that of a specimen of 111In that exhibits major photopeaks having energies of 0.173 and 0.247 MeV.
621), and allow to dry. Repeat applications may be made to obtain a suitable count rate. Develop the chromatogram over a suitable period of time by ascending chromatography, using dilute methanol (8.5 in 10), and dry in an oven at 105 ± 5
for 5 minutes. Determine the radioactivity distribution by scanning the chromatogram with a suitable collimated radiation detector. The radioactivity of the indium pentetic acid complex band is not less than 90.0% of the total radioactivity, and the RF value is between 0.8 and 1.0.
821), determine the radioactivity of each radionuclidic impurity, in kBq per MBq (µCi per mCi) of 111In, in the Injection by use of a calibrated system as directed under Radioactivity 821.
1, except that the Injection may be distributed or dispensed prior to the completion of the test for Sterility, the latter test being started on the day of final manufacture, and except that it is not subject to the recommendation on Volume in Container.
821), determine the radioactivity, in MBq per mL, of Injection by use of a calibrated system as directed under Radioactivity 821.