Technetium Tc 99m Apcitide Injection
» Technetium Tc 99m Apcitide Injection is a sterile aqueous solution for intravenous injection that contains 99mTc in the form of an apcitide complex. It contains not less than 90.0 percent and not more than 110.0 percent of the labeled amount of 99mTc as the apcitide complex expressed in megabecquerels per mL (or in millicuries per mL) at the time indicated in the labeling. Other chemical forms of radioactivity do not exceed 10.0 percent of the total radioactivity. It may contain reducing agents, stabilizing agents, and buffers. It contains no antimicrobial agents.
Packaging and storage Preserve in single-dose containers at controlled room temperature.
Labeling 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 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 CautionRadioactive 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.
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.
pH 791: between 6.0 and 8.0.
Radiochemical purity Separately apply equal volumes (about 10 µL) of Injection, accurately measured, about 1.0 cm from the bottom of each of two 2-cm × 10-cm instant chromatographic silica gel strips. (Do not allow to dry.) Immediately develop the chromatograms by ascending chromatography (see Chromatography 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:
100CS / (CS + PS)in which CS is the count obtained from the top portion of Strip 1; and PS is the count obtained from the bottom portion of Strip 1. Cut Strip 2 at an RF value of about 0.25, and separately record the counts for each portion in a dose calibrator. Calculate the percentage of Tc 99m immobile impurities in the portion of Injection taken by the formula:
100PW / (CW + PW)in which PW is the count obtained from the bottom portion of Strip 2; and CW is the count obtained from the top portion of Strip 2: the sum of hydrophilic and immobile impurities is not more than 10%.
Other requirements 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 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.
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.
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USP32NF27 Page 3658