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Technetium Tc 99m Red Blood Cells Injection
» Technetium Tc 99m Red Blood Cells Injection is a preparation of anticoagulated whole blood that is labeled with 99mTc. The cells are prepared for labeling by collection of an autologous sample of whole blood, which is anticoagulated with Heparin Sodium or anticoagulant dextrose solution.
Technetium Tc 99m Red Blood Cells Injection contains not less than 90.0 percent and not more than 110.0 percent of the labeled concentration of 99mTc as labeled blood cells expressed in megabecquerels (or in microcuries or millicuries) per mL at the time indicated in the labeling. It may contain anticoagulants, such as heparin or anticoagulant citrate solution, chelating agents, stannous chloride, and sodium hypochlorite. Other chemical forms of radioactivity do not exceed 10.0 percent of the total radioactivity. When derived from donor blood, its production and distribution derived from donor blood are subject to federal regulations (see Biologics 1041 and Radioactivity 821).
Caution—A strict aseptic technique must be followed for collection of the blood sample, along with the processing steps required to label it with Technetium Tc 99m. The blood samples must be labeled with the name of the patient and patient's identification code to prevent administration of the sample to other than the intended patient. In the event that donor blood is used, it must first be tested for viral contaminants and carefully typed and cross-matched to ensure compatibility with that of the recipient.
Packaging and storage— Preserve in adequately shielded single-dose or multiple-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 patient's name and identification number; the type of anticoagulant used; the time and date of calibration; the amount expressed as total megabecquerels (or microcuries or millicuries) and concentration as megabecquerels (or microcuries or millicuries) per mL at the time of calibration; the expiration date; 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.
Clarity and color of solution— Observe the appearance and color of the supernatant diluted plasma obtained in the Radiochemical purity test procedure. The diluted plasma is clear and has a colorless to a very slight pink or yellow appearance. Samples that produce a distinctive red coloration are not acceptable for administration.
Bacterial endotoxins 85— It contains 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.
pH 791: between 5.5 and 8.0.
Radiochemical purity— Transfer 0.2 mL of the Injection to a centrifuge tube containing 2 mL of 0.9% sodium chloride solution. Centrifuge for five minutes, and carefully withdraw the diluted plasma by pipet. Measure the radioactivity in the plasma and red blood cells separately in a suitable counter. Calculate labeling efficiency by the formula:
100[ARBC / (ARBC + AP)],
in which ARBC is the activity in the red blood cells, and AP is the activity in the plasma. Not less than 90% of the 99mTc present in the Injection is bound to the red blood cells.
Other requirements— It meets the requirements of the tests for Radionuclide identification and Radionuclidic purity under Sodium Pertechnetate Tc 99m Injection. It meets also the requirements under Injections 1, except that it may be distributed or dispensed prior to completion of the test for Sterility, the latter test being started on the day of final manufacture, and except that it is not subject to the recommendation on Volume in Container.
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 the Injection by use of a calibrated system.
Auxiliary Information— Staff Liaison : Andrzej Wilk, Ph.D., Senior Scientific Associate
Expert Committee : (RMI05) Radiopharmaceuticals and Medical Imaging Agents 05
USP29–NF24 Page 2074
Phone Number : 1-301-816-8305