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 labeled stannous gluceptate 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—
Place a measured volume of Injection, appropriately diluted, such that it provides a count rate of about 20,000 counts per minute, about 25 mm from one end of a 25- × 300-mm strip of chromatographic paper (see
Chromatography 621), and allow to air-dry. With no delay, develop the chromatogram over a suitable period of time by ascending chromatography, using acetone that has been purged with oxygen-free nitrogen for not less than 10 minutes. Allow the chromatogram to dry, and determine the radioactivity distribution by scanning with a suitable collimated radiation detector. Not less than 90.0% of the total radioactivity is found as stannous gluceptate (at the point of application).
Biological distribution—
Constitute 1 vial of Injection with 5 mL to 10 mL of Sodium Pertechnetate Tc 99m Injection. Inject intravenously 0.25 mL of the resulting undiluted Injection into the caudal vein of each of three 150- to 250-g rats. Discard any injections in which extravasation occurs. Approximately 1 hour after the injection, anesthetize the animals and exsanguinate, collecting the blood into a suitable container. Dissect the animals, and place the kidneys, liver, gastrointestinal tract, and a specimen of blood, accurately weighed, 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 kidneys, liver, and gastrointestinal tract taken by the formula:
100Ai / A,
in which
Ai is the net radioactivity in the organ, and
A is the total radioactivity, in MBq (µCi), injected, both corrected to injection time. Determine the percentage of radioactivity in the blood taken by the formula:
[100(B/WS)0.07(WR)]/A,
in which
B is the net radioactivity in the specimen of blood, and
A is the total radioactivity, injected, both corrected to injection time,
WS is the weight, in g, of the blood specimen,
WR is the weight, in g, of the rat, and 0.07 is the assumption that the total blood weight of the rat is 7% of the total body weight. Not less than 15.0% of the radioactivity is found in the kidneys, not more than 5.0% of the radioactivity is found in the blood, not more than 15.0% of the radioactivity is found in the entire gastrointestinal tract and not more than 5.0% of the radioactivity is found in the liver, in not fewer than 2 of the rats.
Other requirements—
It meets the requirements 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 date of manufacture, and except that it is not subject to the recommendation on
Volume in Container.
