Identification

Name
Ammonia N-13
Accession Number
DB09326
Type
Small Molecule
Groups
Approved
Description

Ammonia N 13 Injection, USP is a positron emitting radiopharmaceutical that is used for diagnostic purposes in conjunction with positron emission tomography (PET) imaging. The active ingredient, [13N] ammonia, has the molecular formula of 13NH3 with a molecular weight of 16.02. Ammonia N 13 Injection, USP is used for imaging of the myocardium under rest or pharmacologic stress conditions to evaluate myocardial perfusion in patients with suspected or existing coronary artery disease.

Structure
Thumb
Synonyms
  • (13N)Ammonia
  • Ammonia N 13
Prescription Products
NameDosageStrengthRouteLabellerMarketing StartMarketing End
Ammonia N 13Injection37.5 mCi/1mLIntravenousTHE FEINSTEIN INSTITUTES FOR MEDICAL RESEARCH2007-08-23Not applicableUs
AmmoniaN 13 N 13Injection37.5 mCi/1mLIntravenousChildren's Hospital Of Michigan2012-01-30Not applicableUs
Additional Data Available
  • Application Number
    Application Number

    A unique ID assigned by the FDA when a product is submitted for approval by the labeller.

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  • Product Code
    Product Code

    A governmentally-recognized ID which uniquely identifies the product within its regulatory market.

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Generic Prescription Products
NameDosageStrengthRouteLabellerMarketing StartMarketing End
Ammonia N 13Injection37.5 mCi/1mLIntravenousIonetix Corporation2018-12-21Not applicableUs
Ammonia N 13Injection37.5 mCi/1mLIntravenousSofie Co.2013-01-31Not applicableUs
Ammonia N 13Injection37.5 mCi/1mLIntravenousPetnet Solutions, Inc.2007-08-23Not applicableUs
Ammonia N 13Injection37.5 mCi/1mLIntravenousSpectron Mrc, Llc2015-04-24Not applicableUs
Ammonia N 13Injection37.5 mCi/1mLIntravenousKreitchman Pet Center2013-12-09Not applicableUs
Ammonia N 13Injection37.5 mCi/1mLIntravenous3D Imaging Drug Design and Development LLC2018-12-17Not applicableUs
Ammonia N 13Injection37.5 mCi/1mLIntravenousUniversity Of Texas Md Anderson Cancer Center2013-09-122018-10-22Us
Ammonia N 13Injection, solution37.5 mCi/1mLIntravenousBiomedical Research Foundation Of Northwest Louisiana2015-05-14Not applicableUs
Ammonia N 13Injection260 mCi/1mLIntravenousHouston Cyclotron Partners Lp Dba Cyclotope2011-08-04Not applicableUs
Ammonia N 13Injection37.5 mCi/1mLIntravenousUniversity Of California, Los Angeles2013-06-27Not applicableUs
Additional Data Available
  • Application Number
    Application Number

    A unique ID assigned by the FDA when a product is submitted for approval by the labeller.

    Learn more
  • Product Code
    Product Code

    A governmentally-recognized ID which uniquely identifies the product within its regulatory market.

    Learn more
Unapproved/Other Products
NameIngredientsDosageRouteLabellerMarketing StartMarketing End
AmmoniaN 13 N 13Ammonia N-13 (37.5 mCi/1mL)InjectionIntravenousChildren's Hospital Of Michigan2012-01-30Not applicableUs
Categories
UNII
9OQO0E343Z
CAS number
34819-78-8
Weight
Average: 16.03
Monoisotopic: 16.029213681
Chemical Formula
H3N
InChI Key
QGZKDVFQNNGYKY-BJUDXGSMSA-N
InChI
InChI=1S/H3N/h1H3/i1-1
IUPAC Name
(¹³N)ammonia
SMILES
[13NH3]

Pharmacology

Indication

For diagnostic Positron Emission Tomography (PET) imaging of the myocardium under rest or pharmacologic stress conditions to evaluate myocardial perfusion in patients with suspected or existing coronary artery disease.

Associated Conditions
Pharmacodynamics

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.

Mechanism of action

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.

Additional Data Available
Adverse Effects

Comprehensive structured data on known drug adverse effects with statistical prevalence. MedDRA and ICD10 ids are provided for adverse effect conditions and symptoms.

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Additional Data Available
Contraindications

Structured data covering drug contraindications. Each contraindication describes a scenario in which the drug is not to be used. Includes restrictions on co-administration, contraindicated populations, and more.

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Additional Data Available
Blackbox Warnings

Structured data representing warnings from the black box section of drug labels. These warnings cover important and dangerous risks, contraindications, or adverse effects.

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Absorption

Following intravenous injection, 13N-ammonia is cleared rapidly from the blood with a biologic half-life of about 2.84 minutes (effective half-life of about 2.2 minutes). In the myocardium, its biologic half-life has been estimated to be less than 2 minutes (effective half-life less than 1.67 minutes).

Volume of distribution

0.8 ml/g.

Protein binding

has not been studied.

Metabolism

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.

Route of elimination

Urinary excretion mainly as urea N 13.

Half life

2.84 minutes.

Clearance

The radioactivity cleared from the blood very rapidly with 85% clearance in the first minute.

Toxicity

Data not available.

Affected organisms
Not Available
Pathways
Not Available
Pharmacogenomic Effects/ADRs
Not Available

Interactions

Drug Interactions
This information should not be interpreted without the help of a healthcare provider. If you believe you are experiencing an interaction, contact a healthcare provider immediately. The absence of an interaction does not necessarily mean no interactions exist.
Not Available
Food Interactions
No interactions found.

References

General References
  1. article [Link]
  2. product info [Link]
  3. article [Link]
External Links
PubChem Compound
119432
PubChem Substance
310265208
ChemSpider
106665
RxNav
1305558
ChEBI
135980
ChEMBL
CHEMBL1201189
Wikipedia
Nitrogen-13
FDA label
Download (159 KB)

Clinical Trials

Clinical Trials
PhaseStatusPurposeConditionsCount
Not AvailableNot Yet RecruitingNot AvailableArterial Occlusive Diseases / Arteriosclerosis / Cardiovascular Heart Disease / Coronary Artery Disease / Coronary Heart Disease (CHD) / Heart Diseases / Myocardial Ischemia / Vascular Diseases1

Pharmacoeconomics

Manufacturers
Not Available
Packagers
Not Available
Dosage forms
FormRouteStrength
InjectionIntravenous260 mCi/1mL
Injection, solutionIntravenous37.5 mCi/1mL
Injection, solutionIntravenous260 mCi/1mL
InjectionIntravenous37.5 mCi/1mL
Prices
Not Available
Patents
Not Available

Properties

State
Solid
Experimental Properties
Not Available
Predicted Properties
PropertyValueSource
logP-0.98ChemAxon
pKa (Strongest Basic)8.86ChemAxon
Physiological Charge1ChemAxon
Hydrogen Acceptor Count1ChemAxon
Hydrogen Donor Count1ChemAxon
Polar Surface Area13.59 Å2ChemAxon
Rotatable Bond Count0ChemAxon
Refractivity15.51 m3·mol-1ChemAxon
Polarizability1.99 Å3ChemAxon
Number of Rings0ChemAxon
Bioavailability1ChemAxon
Rule of FiveYesChemAxon
Ghose FilterNoChemAxon
Veber's RuleYesChemAxon
MDDR-like RuleNoChemAxon
Predicted ADMET features
Not Available

Spectra

Mass Spec (NIST)
Not Available
Spectra
SpectrumSpectrum TypeSplash Key
Predicted GC-MS Spectrum - GC-MSPredicted GC-MSNot Available
Predicted MS/MS Spectrum - 10V, Positive (Annotated)Predicted LC-MS/MSNot Available
Predicted MS/MS Spectrum - 20V, Positive (Annotated)Predicted LC-MS/MSNot Available
Predicted MS/MS Spectrum - 40V, Positive (Annotated)Predicted LC-MS/MSNot Available
Predicted MS/MS Spectrum - 10V, Negative (Annotated)Predicted LC-MS/MSNot Available
Predicted MS/MS Spectrum - 20V, Negative (Annotated)Predicted LC-MS/MSNot Available
Predicted MS/MS Spectrum - 40V, Negative (Annotated)Predicted LC-MS/MSNot Available

Taxonomy

Description
This compound belongs to the class of inorganic compounds known as homogeneous other non-metal compounds. These are inorganic non-metallic compounds in which the largest atom belongs to the class of 'other non-metals'.
Kingdom
Inorganic compounds
Super Class
Homogeneous non-metal compounds
Class
Homogeneous other non-metal compounds
Sub Class
Not Available
Direct Parent
Homogeneous other non-metal compounds
Alternative Parents
Not Available
Substituents
Homogeneous other non metal
Molecular Framework
Not Available
External Descriptors
Not Available

Enzymes

Kind
Protein
Organism
Humans
Pharmacological action
Yes
Actions
Substrate
General Function
Arginine binding
Specific Function
Plays a role in the regulation of ureagenesis by producing the essential cofactor N-acetylglutamate (NAG), thus modulating carbamoylphosphate synthase I (CPSI) activity.
Gene Name
NAGS
Uniprot ID
Q8N159
Uniprot Name
N-acetylglutamate synthase, mitochondrial
Molecular Weight
58155.835 Da

Transporters

Kind
Protein
Organism
Humans
Pharmacological action
Unknown
Actions
Transporter
General Function
Ankyrin binding
Specific Function
Functions as an electroneutral and bidirectional ammonium transporter. May regulate transepithelial ammonia secretion.
Gene Name
RHCG
Uniprot ID
Q9UBD6
Uniprot Name
Ammonium transporter Rh type C
Molecular Weight
53178.56 Da

Drug created on November 17, 2015 11:59 / Updated on May 26, 2020 02:54

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