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Urea-14C

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FINISHED DOSAGE FORMULATIONS

3 FDF Dossiers, 2 FDA Orange Book, 1 Europe

3 FDF Dossiers
2 FDA Orange Book
1 Europe

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Chemistry

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Also known as: Urea-14c, 14c-urea, Urea c-14, Urea c 14, Carbon 14 urea, Carbon-14 urea

Molecular Formula

CH₄N₂O

Molecular Weight

62.048 g/mol

InChI Key

XSQUKJJJFZCRTK-NJFSPNSNSA-N

FDA UNII

WBZ6M63TEE

Urea C-14 is a radiolabelled urea molecule used to diagnose stomach ulcers caused by Heliobacter pylori. In the presence of H. pylori, urea C-14 is metabolized by urease to produce ammonia and radioactive carbon dioxide at the interface between the gastric epithelium and lumen. The radioactive carbon dioxide is absorbed in the blood and is detected when exhaled in the breath.

1 2D Structure

Urea-14C

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

diamino(114C)methanone

2.1.2 InChI

InChI=1S/CH4N2O/c2-1(3)4/h(H4,2,3,4)/i1+2

2.1.3 InChI Key

XSQUKJJJFZCRTK-NJFSPNSNSA-N

2.1.4 Canonical SMILES

C(=O)(N)N

2.1.5 Isomeric SMILES

[14C](=O)(N)N

2.2 Other Identifiers

2.2.1 UNII

WBZ6M63TEE

2.3 Synonyms

2.3.1 Depositor-Supplied Synonyms

1. Urea-14c

2. 14c-urea

3. Urea C-14

4. Urea C 14

5. Carbon 14 Urea

6. Carbon-14 Urea

7. Urea ((sup 14)c)

8. Urea (14c)

9. 594-05-8

10. Urea 14 C

11. Diamino(114c)methanone

12. Wbz6m63tee

13. Pytest

14. Unii-wbz6m63tee

15. Urea C 14 [usp]

16. Pytest (tn)

17. Urea C14 (usp)

18. Chembl2096635

19. Urea 14 C [who-dd]

20. Urea, [14c]

21. Chebi:134711

22. Dtxsid701026303

23. Urea C 14 [usp Impurity]

24. Urea, C-14 [orange Book]

25. Db09513

26. D10496

27. Q27098010

2.4 Create Date

2006-10-26

3 Chemical and Physical Properties

Molecular Formula	CH₄N₂O
Molecular Weight	62.048 g/mol
XLogP3	-1.4
Hydrogen Bond Donor Count	2
Hydrogen Bond Acceptor Count	1
Rotatable Bond Count	0
Exact Mass	62.03560474 g/mol
Monoisotopic Mass	62.03560474 g/mol
Topological Polar Surface Area	69.1 Å²
Heavy Atom Count	4
Formal Charge	0
Complexity	29
Isotope Atom Count	1
Defined Atom Stereocenter Count	0
Undefined Atom Stereocenter Count	0
Defined Bond Stereocenter Count	0
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	1

4 Drug and Medication Information

4.1 Drug Information

1 of 2
Drug Name	Pytest
PubMed Health	14C-Urea (By mouth)
Drug Classes	Diagnostic Agent, Helicobactor Pylori, Breath Test
Active Ingredient	Urea, c-14
Dosage Form	Capsule
Route	Oral
Strength	1uci
Market Status	Prescription
Company	Avent

2 of 2
Drug Name	Pytest
PubMed Health	14C-Urea (By mouth)
Drug Classes	Diagnostic Agent, Helicobactor Pylori, Breath Test
Active Ingredient	Urea, c-14
Dosage Form	Capsule
Route	Oral
Strength	1uci
Market Status	Prescription
Company	Avent

4.2 Drug Indication

14C-urea is intended for use in the detection of gastric urease as an aid in the diagnosis of Helicobacter pylori (H. pylori) infection in the human stomach. The test utilizes a liquid scintillation counter for the measurement of 14CO2 in breath samples.

FDA Label

5 Pharmacology and Biochemistry

5.1 Biological Half-Life

14C-urea that is not hydrolyzed by H. pylori is excreted in the urine with a half-life of approximately 12 hours. About 10% of the 14C remains in the body at 72 hours and is gradually excreted with a biological half-life of 40 days.

5.2 Mechanism of Action

The urease enzyme is not present in mammalian cells, so the presence of urease in the stomach is evidence that bacteria are present. The presence of urease is not specific for H. pylori, but other bacteria are not usually found in the stomach. To detect H. pylori, urea labeled with 14C is swallowed by the patient. If gastric urease from H. pylori is present, urea is split to form CO2 and NH3 at the interface between the gastric epithelium and lumen and 14CO2 is absorbed into the blood and exhaled in the breath. Following ingestion of the capsule by a patient with H. pylori, 14CO2 excretion in the breath peaks between 10 and 15 minutes and declines thereafter with a biological half-life of about 15 minutes. Therefore, the detection of isotope-labelled carbon dioxide in exhaled breath indicates that urease is present in the stomach, and hence that H. pylori bacteria are present.

FDF Dossiers