Technetium Tc 99m Depreotide Injection
» Technetium Tc 99m Depreotide Injection is a sterile, aqueous solution suitable for intravenous injection that contains 99mTc in the form of a depreotide complex. It contains not less than 90.0 percent and not more than 110.0 percent of the labeled amount of 99mTc as the depreotide complex expressed in megabecquerels (or in millicuries) per mL at the time indicated in the labeling. It may contain reducing agents, stabilizing agents, and buffers. It contains no antimicrobial agents. Other chemical forms of radioactivity do not exceed 10.0 percent of the total radioactivity.
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 depreotide complex 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.
USP Reference standards 11
USP Endotoxin RS
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 1.5-cm × 10-cm instant chromatographic silica gel strips. Do not allow the plates 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 a mixture of methanol and 1 M ammonium acetate (1:1) 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 cut Strip 2 at an RF value of about 0.40. Separately record the counts for each portion in a dose calibrator. Calculate the percentage of nonmobile impurities in the portion of Injection taken by the formula:
100CM / (CM + PM)
in which CM is the count obtained from the bottom portion of Strip 2; and PM is the count obtained from the top portion of Strip 2. Calculate the percentage of Tc 99m pertechnetate, Tc 99m glucoheptonate, and Tc 99m edetate in the portion of Injection taken by the formula:
100PS / (CS + PS)
in which PS is the count obtained from the top portion of Strip 1; and CS is the count obtained from the bottom portion of Strip 1: not more than 10% of total impurities is found.
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 the Injection is not subject to the recommendation on Volume in Container, and 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.
Assay for radioactivity 821 Using a suitable counting assembly, determine the radioactivity, in MBq (or mCi) per mL, of Injection by use of a calibrated system.
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Topic/Question Contact Expert Committee
Monograph Ravi Ravichandran, Ph.D.
Principal Scientific Liaison
(SM42010) Monographs - Small Molecules 4
Reference Standards RS Technical Services
85 Radhakrishna S Tirumalai, Ph.D.
Principal Scientific Liaison
(GCM2010) General Chapters - Microbiology
USP35–NF30 Page 4761
Pharmacopeial Forum: Volume No. 27(3) Page 2583