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1
: the time and date of calibration; the amount of 99mTc as labeled apcitide complex expressed as total megabecquerels per mL (or millicuries 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.
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 6.0 and 8.0.
621), until the solvents reach the top of the strips, using saturated sodium chloride solution as the developing solvent for one strip (Strip 1) and water for the other strip (Strip 2). Remove the strips, and allow to air-dry. Cut Strip 1 at an RF value of about 0.75, and separately record the counts for each portion in a dose calibrator. Calculate the percentage of Tc 99m pertechnetate and Tc 99m glucoheptonate (hydrophilic impurities) in the portion of Injection taken by the formula:
1, except that it is not subject to the recommendation on Volume in Container and 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.