Packaging and storage—
Preserve in single-dose or 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 labeled tetrasodium pyrophosphate 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 time; 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.
Radiochemical purity—
The determination of radiochemical purity for this product requires the use of two separate chromatography systems.
System A—
Under an atmosphere of nitrogen, place a measured volume of Injection, appropriately diluted, such that it provides a count rate of about 20,000 counts per minute, about 20 mm from one end of a thin-layer chromatographic strip impregnated with silica gel (see
Chromatography 621), and allow to dry. Develop the chromatogram over a suitable period by ascending chromatography, using
saline TS, and dry it under nitrogen. Determine the radioactivity distribution by scanning the chromatogram with a suitable collimated radiation detector. Hydrolyzed Tc 99m and technetium-tin colloid are located at the origin (
RF 0 to 0.1).
System B—
Proceed as directed for System A, except to develop the chromatogram in a mixture of methanol and acetone (1:1). Free pertechnetate is located at the solvent front. The sum of the percentage of radioactivity at the origin in System A plus the percentage of radioactivity at the solvent front in System B is not greater than 10.0%.
Biological distribution—
Inject intravenously between 0.075 MBq and 75 MBq (2 µCi and 2 mCi) of Injection, in a volume not exceeding 0.2 mL, into the caudal or external jugular vein of each of three 175- to 250-g rats. Approximately 1 hour after the injection, sacrifice the animals, and carefully remove the liver, both kidneys, and one femur of each by dissection, freeing the femur from soft tissue. Remove the tail 20 to 30 mm above the injection site, and discard. Place each organ, both kidneys, and the remaining carcass in separate, suitable counting containers, and 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, kidneys, and femur taken by the formula:
100(A / B),
in which
A is the net radioactivity, in counts per minute, in the organ, and
B is the total radioactivity, in counts per minute, in the liver, kidneys, femur, and carcass. Not more than 5.0% of the total radioactivity is found in the liver or in the kidneys, and not less than 1.0% of the total radioactivity is found in the femur, in not fewer than 2 of the rats.
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.
