11.2 Physical Characteristics
Nitrogen N13 decays by emitting positron to Carbon C13 (stable) and has a physical half-life of 9.96 minutes. The principal photons useful for imaging are the dual 511 keV gamma photons that are produced and emitted simultaneously in opposite direction when the positron interacts with an electron (Table 2).
|Radiation/Emission||% Per Disintegration||Energy|
|Positron(β+)||100||1190 keV (Max.)|
*Produced by positron annihilationThe specific gamma ray constant (point source air kerma coefficient) for nitrogen N13 is 5.9 R/hr/mCi (1.39 x 10-6 Gy/hr/kBq) at 1 cm. The half-value layer (HVL) of lead (Pb) for 511 keV photons is 4 mm. Selected coefficients of attenuation are listed in Table 3 as a function of lead shield thickness. For example, the use of 39 mm thickness of lead will attenuate the external radiation by a factor of about 1000.
|Shield Thickness (Pb) mm||Coefficient of Attenuation|
Table 4 lists fractions remaining at selected time intervals from the calibration time. This information may be used to correct for physical decay of the radionuclide.
Ammonia N 13 Injection is a radiolabeled analog of ammonia that is distributed to all organs of the body after intravenous administration. It is extracted from the blood in the coronary capillaries into the myocardial cells where it is metabolized to glutamine N 13 and retained in the cells. The presence of ammonia N 13 and glutamine N 13 in the myocardium allows for PET imaging of the myocardium.
Following intravenous injection, ammonia N 13 enters the myocardium through the coronary arteries. The PET technique measures myocardial blood flow based on the assumption of a three-compartmental disposition of intravenous ammonia N 13 in the myocardium. In this model, the value of the rate constant, which represents the delivery of blood to myocardium, and the fraction of ammonia N 13 extracted into the myocardial cells, is a measure of myocardial blood flow. Optimal PET imaging of the myocardium is generally achieved between 10 to 20 minutes after administration.
Following intravenous injection, Ammonia N 13
Injection is cleared from the blood with a biologic half-life of
about 2.84 minutes (effective half-life of about 2.21 minutes). In the myocardium, its biologic half-life has
been estimated to be less than 2 minutes (effective half-life less than 1.67
The mass dose of Ammonia N 13 Injection is very
small as compared to the normal range of ammonia in the blood
(0.72-3.30 mg) in a healthy adult man [see Description (11.1)].
Plasma protein binding of ammonia N 13 or its N
13 metabolites has not been
Ammonia N 13 undergoes a five-enzyme step
metabolism in the liver to yield
urea N 13 (the main circulating metabolite).
It is also metabolized to glutamine N 13 (the main metabolite in
tissues) by glutamine synthesis in the skeletal muscles, liver, brain,
myocardium, and other organs. Other
metabolites of ammonia N 13 include small amounts of N 13 amino acid anions
(acidic amino acids) in the forms of glutamate N 13 or aspartate N 13.
Ammonia N 13 is eliminated from the body by
urinary excretion mainly as urea
The pharmacokinetics of Ammonia N 13 Injection have not been studied in renally impaired, hepatically impaired, or pediatric patients.
Long term animal studies have not been performed to evaluate the carcinogenic potential of Ammonia N 13 Injection. Genotoxicity assays and impairment of male and female fertility studies with Ammonia N 13 Injection have not been performed.
In a descriptive, prospective, blinded image interpretation study2 of adult patients with known or suspected coronary artery disease, myocardial perfusion deficits in stress and rest PET images obtained with Ammonia N 13 (N=111) or Rubidium 82 (N=82) were compared to changes in stenosis flow reserve (SFR) as determined by coronary angiography. The principal outcome of the study was the evaluation of PET defect severity relative to SFR.
PET perfusion defects at rest and stress for seven
apical, anteroseptal, posteroseptal, anterolateral, posterolateral, and
inferior walls) were graded on a 0 to 5 scale defined as normal (0), possible
(1), probable (2), mild (3), moderate (4), and severe (5) defects. Coronary
angiograms were used to measure absolute and relative stenosis dimensions and
to calculate stenosis flow reserve defined as the maximum value of flow at
maximum coronary vasodilatation relative to rest flow under standardized
hemodynamic conditions. SFR scores
ranged from 0 (total occlusion) to 5 (normal).
With increasing impairment of flow reserve, the subjective PET defect severity increased. A PET defect score of 2 or higher was positively correlated with flow reserve impairment (SFR<3).
- Annals of the ICRP. Publication 53. Radiation dose to patients
from radiopharmaceuticals. New York: Pergamon
- Demer, L.L.K.L.Gould, R.A.Goldstein, R.L.Kirkeeide, N.A.Mullani, R.W. Smalling, A.Nishikawa, and M.E.Merhige. Assessment of coronary artery disease severity by PET: Comparison with quantitative arteriography in 193 patients. Circulation 1989; 79: 825-35.
Ammonia N 13 Injection is packaged in 10 mL mulitiple dose glass vial containing between 1.11 GBq to 11.1 GBq (30 mCi to 300 mCi) of [13 N] ammonia, at the end of synthesis (EOS) reference time, in 0.9% sodium chloride injection solution in approximately 8 mL volume. The recommended dose of radioactivity (10-20 mCi) is associated with a theoretical mass dose of 0.5-1 picomoles (8.47-16.94 picograms) of Ammonia.
Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F).Use the solution within 35 minutes of the End of Synthesis (EOS) calibration.
Instruct patients to drink plenty of water or other fluids (as tolerated) in the 4 hours before their PET study.
17.2 Post-study Voiding
Instruct patients to void after completion of each image acquisition session and as often as possible for one hour after the PET scan ends.
17.3 Post-study Breastfeeding Avoidance
Instruct nursing patients to substitute stored breast milk or infant formula for breast milk for 2 hours after administration of Ammonia N 13 Injection.
Manufactured and Distributed by:
University of Wisconsin Radiopharmaceutical Production Facility
Madison, Wisconsin 53705
Drug Product Vial Label
Drug Product Shield Label
|AMMONIA N 13 ammonia n 13 injection|
|Labeler — University of Wisconsin System (161202122)|
|Registrant — University of Wisconsin System (161202122)|
|UW Radiopharmaceutical Production Facility||117218915||positron emission tomography drug production (72333-001)|
Revised: 10/2022 University of Wisconsin System
All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.