Find Ammonia N13 manufacturers, exporters & distributors on PharmaCompass

PharmaCompass

Synopsis

Synopsis

ACTIVE PHARMA INGREDIENTS

0

API Suppliers

API Suppliers

0

USDMF

US DMFs Filed

0

CEP/COS

CEP/COS Certifications

0

JDMF

JDMFs Filed

0

EU WC

EU WC

0

KDMF

KDMF

0

NDC API

NDC API

0

VMF

NDC API

0

Listed Suppliers

Other Suppliers

API REF. PRICE (USD/KG)

$
$ 0

MARKET PLACE

0

API

0

FDF

0INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

0

Europe

Europe

0

Canada

Canada

0

Australia

Australia

0

South Africa

South Africa

0

Listed Dossiers

Listed Dossiers

0 DRUGS IN DEVELOPMENT

FDF Dossiers

DRUG PRODUCT COMPOSITIONS

REF. STANDARDS OR IMPURITIES

0

EDQM

0

USP

0

JP

0

Others

PATENTS & EXCLUSIVITIES

0

US Patents

0

US Exclusivities

0

Health Canada Patents

DIGITAL CONTENT

0

Data Compilation #PharmaFlow

0

Stock Recap #PipelineProspector

0

Weekly News Recap #Phispers

GLOBAL SALES INFORMATION

US Medicaid

NA

Annual Reports

NA

Finished Drug Prices

NA

2 RELATED EXCIPIENT COMPANIES

2EXCIPIENTS BY APPLICATIONS

Chemistry

Click the arrow to open the dropdown
read-moreClick the button for full data set
Also known as: Ammonia n 13, Ammonia-(sup 13)n, ((sup 13)n)ammonia, Ammonia n13, 34819-78-8, Ammonia, n-13
Molecular Formula
H3N
Molecular Weight
16.030  g/mol
InChI Key
QGZKDVFQNNGYKY-BJUDXGSMSA-N
FDA UNII
9OQO0E343Z

Ammonia N13
Ammonia N-13 is a radiopharmaceutical composed of ammonia labeled with the radioisotope nitrogen N 13 that can be used, during positron emission tomography (PET), as a blood flow imaging agent and potentially as a tumor imaging agent. Upon intravenous administration, ammonia N 13 distributes to various organs in the body, such as the myocardium, liver, kidneys and brain. This agent is taken up by cells and is retained following conversion to glutamine N 13 by glutamine synthetase (GS). Upon PET, organ perfusion and the presence of cancer cells can be assessed. GS, an enzyme that catalyzes the synthesis of glutamine from glutamate and ammonia, is overexpressed in a variety of cancers and plays a key role in cancer cell proliferation.
Ammonia n-13 is a Radioactive Diagnostic Agent. The mechanism of action of ammonia n-13 is as a Radiopharmaceutical Activity.
1 2D Structure

Ammonia N13

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
azane
2.1.2 InChI
InChI=1S/H3N/h1H3/i1-1
2.1.3 InChI Key
QGZKDVFQNNGYKY-BJUDXGSMSA-N
2.1.4 Canonical SMILES
N
2.1.5 Isomeric SMILES
[13NH3]
2.2 Other Identifiers
2.2.1 UNII
9OQO0E343Z
2.3 Synonyms
2.3.1 Depositor-Supplied Synonyms

1. Ammonia N 13

2. Ammonia-(sup 13)n

3. ((sup 13)n)ammonia

4. Ammonia N13

5. 34819-78-8

6. Ammonia, N-13

7. 9oqo0e343z

8. (13n)ammonia

9. [13n]ammonia

10. 13n-ammonia

11. N-13 Ammonia

12. Ammonia N 13 Injection

13. Ammonia N 13 [usan]

14. Unii-9oqo0e343z

15. Ammonia N 13 [usan:usp]

16. Ammonia-13n

17. Nitrogen, Isotope Of Mass 13, At.

18. Ammonia-(13)n

19. Ammonia (13n)

20. Ammonia ((13)n)

21. Ammonia N 13 (tn)

22. Ammonia N 13 (usp)

23. Chembl1201189

24. Chebi:135980

25. 13nh3

26. Dtxsid601027603

27. Moli001000

28. Moli001060

29. [13n]nh3

30. Ammonia (13n) [who-dd]

31. Ammonia N-13 [orange Book]

32. Ammonia N 13 [usp Impurity]

33. (13)nh3

34. Ammonia, N-13 [orange Book]

35. Db09326

36. H3[(13)n]

37. D02915

38. Q27098001

2.4 Create Date
2005-03-27
3 Chemical and Physical Properties
Molecular Weight 16.030 g/mol
Molecular Formula H3N
XLogP3-0.7
Hydrogen Bond Donor Count1
Hydrogen Bond Acceptor Count1
Rotatable Bond Count0
Exact Mass16.029214 g/mol
Monoisotopic Mass16.029214 g/mol
Topological Polar Surface Area1 Ų
Heavy Atom Count1
Formal Charge0
Complexity0
Isotope Atom Count1
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1
4 Drug and Medication Information
4.1 Drug Information
1 of 2  
Drug NameAmmonia n 13
Active IngredientAmmonia n-13
Dosage FormInjectable
RouteIntravenous
Strength30mci-300mci/8ml (3.75-37.5mci/ml); 3.75-260mci/ml
Market StatusPrescription
CompanyUcsf Rodiopharm; Feinstein; Johns Hopkins Univ; Ucla Biomedical; Cardinal Health 414; Wa Univ Sch Med; Shertech Labs; Univ Tx Md Anderson; Houston Cyclotron; Mcprf; Kreitchman Pet Ctr

2 of 2  
Drug NameAmmonia n 13
Active IngredientAmmonia n-13
Dosage FormInjectable
RouteIntravenous
Strength30mci-300mci/8ml (3.75-37.5mci/ml); 3.75-260mci/ml
Market StatusPrescription
CompanyUcsf Rodiopharm; Feinstein; Johns Hopkins Univ; Ucla Biomedical; Cardinal Health 414; Wa Univ Sch Med; Shertech Labs; Univ Tx Md Anderson; Houston Cyclotron; Mcprf; Kreitchman Pet Ctr

4.2 Drug 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.


FDA Label


5 Pharmacology and Biochemistry
5.1 Pharmacology

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.


5.2 FDA Pharmacological Classification
5.2.1 Active Moiety
AMMONIA N-13
5.2.2 FDA UNII
9OQO0E343Z
5.2.3 Pharmacological Classes
Radiopharmaceutical Activity [MoA]; Radioactive Diagnostic Agent [EPC]
5.3 ATC Code

V - Various

V09 - Diagnostic radiopharmaceuticals

V09G - Cardiovascular system

V09GX - Other cardiovascular system diagnostic radiopharmaceuticals

V09GX05 - Ammonia (13N)


5.4 Absorption, Distribution and Excretion

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).


Route of Elimination

Urinary excretion mainly as urea N 13.


Volume of Distribution

0.8 ml/g.


Clearance

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


5.5 Metabolism/Metabolites

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.


5.6 Biological Half-Life

2.84 minutes.


5.7 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.


Related Excipient Companies

Upload your portfolio for free, ask us

Digital Content read-more

Create Content with PharmaCompass, ask us

NEWS #PharmaBuzz

read-more
read-more

ABOUT THIS PAGE

Ammonia N13 Manufacturers

A Ammonia N13 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ammonia N13, including repackagers and relabelers. The FDA regulates Ammonia N13 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ammonia N13 API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

Ammonia N13 Suppliers

A Ammonia N13 supplier is an individual or a company that provides Ammonia N13 active pharmaceutical ingredient (API) or Ammonia N13 finished formulations upon request. The Ammonia N13 suppliers may include Ammonia N13 API manufacturers, exporters, distributors and traders.

Ammonia N13 GMP

Ammonia N13 Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.

GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).

PharmaCompass offers a list of Ammonia N13 GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Ammonia N13 GMP manufacturer or Ammonia N13 GMP API supplier for your needs.

Ammonia N13 CoA

A Ammonia N13 CoA (Certificate of Analysis) is a formal document that attests to Ammonia N13's compliance with Ammonia N13 specifications and serves as a tool for batch-level quality control.

Ammonia N13 CoA mostly includes findings from lab analyses of a specific batch. For each Ammonia N13 CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.

Ammonia N13 may be tested according to a variety of international standards, such as European Pharmacopoeia (Ammonia N13 EP), Ammonia N13 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Ammonia N13 USP).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
Ask Us for Pharmaceutical Supplier and Partner
Ask Us, Find A Supplier / Partner
No Commissions, No Strings Attached, Get Connected for FREE

What are you looking for?

How can we help you?

The request can't be empty

Please read our Privacy Policy carefully

You must agree to the privacy policy

The name can't be empty
The company can't be empty.
The email can't be empty Please enter a valid email.
The mobile can't be empty