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[41183-64-6; 52260-70-5].
1
: the time and date of calibration; the amount of 67Ga as labeled gallium citrate expressed as total megabecquerels (MBq) (microcuries [µCi] or millicuries [mCi]) and concentration as megabecquerels (µCi or mCi) per mL at the time of calibration; the expiration date and time; and the statement “Caution—Radioactive Material.” The labeling indicates that in making dosage calibrations, correction is to be made for radioactive decay, and also indicates that the radioactive half-life of 67Ga is 78.26 hours.
85—
It meets the requirements of the Bacterial Endotoxins Test, the limit of endotoxin content being 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 or time.
791:
between 4.5 and 8.0.
621). While spots are wet, immediately develop the chromatogram at room temperature to the 14-cm mark by ascending chromatography, using a solvent system consisting of a mixture of 1.36 g of sodium acetate and 0.58 mL of glacial acetic acid in each 100 mL of water. Allow the strip to partially dry, cover with clear tape, and determine the radioactivity distribution by scanning the chromatogram with a suitable collimated radiation detector: not less than 97.0% of the total radioactivity is found as gallium citrate when measured at the solvent front (RF value equal to or greater than 0.9).
821)—
Its gamma-ray spectrum is identical to that of a specimen of 67Ga of known purity that exhibits major photopeaks having energies of 93.3, 184.6, and 300.2 KeV.
821), determine the radionuclidic purity of the Injection: not less than 99% of the total radioactivity is present as 67Ga at the time of calibration.
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 manufacture, and except that it is not subject to the recommendation on Volume in Container.
821), determine the radioactivity in MBq (µCi or mCi) per mL of Gallium Ga 67 Injection by use of a calibrated system as directed under Radioactivity 821.