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Technetium Tc 99m Albumin Injection
» Technetium Tc 99m Albumin Injection is a sterile, aqueous solution, suitable for intravenous administration, of Albumin Human that is labeled with 99mTc.
It contains not less than 90.0 percent and not more than 110.0 percent of the labeled amount of 99mTc as albumin expressed in megabecquerels (microcuries or millicuries) per mL at the time indicated in the labeling. It may contain antimicrobial agents, buffers, reducing agents, and stabilizers. Other chemical forms of radioactivity do not exceed 10.0 percent of the total radioactivity. Its production and distribution are subject to federal regulations (see Biologics 1041 and Radioactivity 821).
Packaging and storage— Preserve in single-dose or in multiple-dose containers, at a temperature between 2 and 8.
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 albumin expressed as total megabecquerels (microcuries or millicuries) and concentration as megabecquerels (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.
Bacterial endotoxins 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 or time.
pH 791: between 2.5 and 5.0.
Radiochemical purity— Not more than 10.0% of unbound Tc 99m (free pertechnetate) and reduced Tc 99m is present, determined as follows.
System A— Place a measured volume of Injection, such that it provides a count rate of about 100,000 counts per minute, about 3 cm from the end of a 2- × 17-cm thin-layer chromatographic strip impregnated with silica gel (see Chromatography 621), and allow to dry. Develop the chromatogram over a suitable period (approximately 30 minutes) by ascending chromatography, using acetone, and air-dry. Determine the radioactivity distribution by scanning the chromatograph with a suitable collimated radiation detector. Reduced Tc 99m and Tc 99m labeled albumin are located at the origin (RF 0 to 0.1). Not more than 5.0% of the total radioactivity is found as unbound Tc 99m (free pertechnetate) at the solvent front (RF 0.9 to 1.0).
System B— Prepare a 4- × 30-cm strip of chromatographic paper by immersing in 1% human serum albumin for 30 minutes and air-drying for 2 to 4 hours. Place a measured volume of Injection (about 3 µL) on the strip, mark the origin, and allow to dry. Develop the chromatogram by descending chromatography (see Chromatography 621), using nitrogen-purged saline TS until the solvent front has moved approximately 15 cm from the origin, mark the solvent front, and air-dry. Determine the radioactivity distribution by scanning the chromatogram with a suitable collimated radiation detector. Unbound Tc 99m and Tc 99m labeled albumin are at the solvent front (RF 0.7 to 1.0). Not more than 5.0% of the total radioactivity is found as reduced Tc 99m at the origin (RF 0 to 0.1).
Biological distribution— Inject intravenously between 0.075 MBq and 185 MBq (2 µCi and 5 mCi) of the Injection in a volume not exceeding 0.2 mL into the caudal vein of each of two 20- to 25-g mice. Approximately 30 minutes after the injection, sacrifice the animals, and drain the blood into a suitable container. Dissect the animals, and place the liver, stomach, and a 1-g specimen of blood, accurately weighed, in separate, suitable counting containers, and discard the tail cut above the injection site. Determine the radioactivity, in counts per minute, in each container with an appropriate detector, using the same counting geometry. Determine the percentage of radioactivity in the liver and stomach taken by the formula:
100(Ai / A),
in which Ai is the net radioactivity, in counts per minute, in the organ, and A is the total radioactivity, in counts per minute, in the liver, stomach, blood, and carcass. Determine the percentage of radioactivity in the blood taken by the formula:
[100(B / WS)0.078(WR)] / A,
in which B is the net radioactivity, in counts per minute, in the specimen of blood, WS is the weight, in g, of the blood specimen, WR is the weight, in g, of the mouse, and 0.078 is the assumption that the total blood weight of the mouse is 7.8% of the total body weight. Not more than 15.0% of the radioactivity is found in the liver, and not more than 1.0% of the radioactivity is found in the stomach. Not less than 30.0% of the radioactivity is found in the blood.
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 (µCi) per mL, of Technetium Tc 99m Albumin 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 2059
Phone Number : 1-301-816-8305