Packaging and storage—
Preserve in 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 time and date of calibration; the amount of
99mTc as labeled exametazime expressed as total megabecquerels (or as total microcuries or millicuries) and concentration as megabecquerels (or as microcuries or millicuries) per mL at the time of calibration; the expiration date and time; and a 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.
[NOTE—The label states that, upon constitution with Sodium Pertechnetate Tc 99m Injection, the beyond-use time is 30 minutes for the unstabilized Injection and between 4 hours and 6 hours for the stabilized Injection.
]
pH 791:
between 9.0 and 9.8 for unstabilized Injection, and between 6.5 and 7.5 for stabilized Injection.
Radiochemical purity—
Prepare three 12- × 75-mm chromatographic tubes by packing with about 0.3 mL of fresh methyl ethyl ketone, 0.9% nonbacteriostatic sodium chloride solution, and a 50% acetonitrile solution, prepared with nonbacteriostatic water, respectively. To each of two 6- × 0.7-cm instant thin-layer chromatographic strips
1 and one 6- × 0.7-cm strip of chromatographic paper
2 , apply 5 µL of freshly prepared (within 2 minutes of reconstitution) Injection about 1 cm from the bottom of the strip. Do not allow to dry. Place one instant thin-layer chromatographic strip into the tube containing methyl ethyl ketone, the second instant thin-layer chromatographic strip into the tube containing the 0.9% sodium chloride solution, and the paper strip into the tube containing the 50% acetonitrile solution. The strips must not adhere to the sides of the tubes. Allow the chromatograms to develop until the solvent front has moved to the top of the strips. Remove the strips from the tubes, and allow the solvents to evaporate. Determine the radioactive distribution by scanning the strip sections, using a suitable collimated radiation detector. The difference between the radioactivity detected at the origin of the 0.9% sodium chloride strip and at the origin of the methyl ethyl ketone strip represents the primary lipophilic
99mTc exametazime complex. The radioactivity at the solvent front of the 0.9% sodium chloride strip represents the
99mTc pertechnetate radiochemical impurity. The radioactivity at the origin of the 50% acetonitrile strip represents the
99mTc hydrolyzed, reduced radiochemical impurity. The difference between the radioactivity detected at the origin of the methyl ethyl ketone strip and the origin of the 50% acetonitrile strip represents the secondary
99mTc exametazime complex radiochemical impurity. Not less than 80% of the total radioactivity is found as primary lipophilic
99mTc exametazime complex.
[NOTE—Complete the measurement within 30 minutes after constitution of the unstabilized Injection and between 4 hours and 6 hours after constitution of the stabilized Injection.
]
Biological distribution—
Inject between 18.5 MBq and 37 MBq (between 0.5 mCi and 1 mCi) of Injection in a volume not exceeding 0.1 mL into the caudal vein of each of three 130- to 190-g Sprague-Dawley rats. Five to ten minutes after the injection, sacrifice the animals and carefully remove the brain, liver, and intestines (including gall bladder). Place each organ 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 brain, liver, intestines, and remaining carcass 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 brain, liver, intestines, and carcass. Not less than 1.5% of the radioactivity is found in the brain. Not more than 20% of the radioactivity is found in the intestines, and not more than 15% of the radioactivity is found in the liver, in not less than two of the animals.
Other requirements—
It meets the requirements of the tests for
Radionuclidic identification and
Radionuclide purity and
Bacterial endotoxins 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 manufacture, and except that it is not subject to the recommendation on
Volume in Container.
