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1
, and store at controlled room temperature.
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.
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.
791:
between 5.0 and 7.0.
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.
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 mCi) per mL, of Injection by use of a calibrated system.