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    Urea-14C

    FINISHED DOSAGE FORMULATIONS

    DIGITAL CONTENT

    PharmaCompass
    Xls

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    2D Structure
    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

    2D Structure

    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 Weight 62.048 g/mol
    Molecular Formula CH4N2O
    XLogP3-1.4
    Hydrogen Bond Donor Count2
    Hydrogen Bond Acceptor Count1
    Rotatable Bond Count0
    Exact Mass62.03560474 g/mol
    Monoisotopic Mass62.03560474 g/mol
    Topological Polar Surface Area69.1 Ų
    Heavy Atom Count4
    Formal Charge0
    Complexity29
    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 NamePytest
    PubMed Health14C-Urea (By mouth)
    Drug ClassesDiagnostic Agent, Helicobactor Pylori, Breath Test
    Active IngredientUrea, c-14
    Dosage FormCapsule
    RouteOral
    Strength1uci
    Market StatusPrescription
    CompanyAvent

    2 of 2  
    Drug NamePytest
    PubMed Health14C-Urea (By mouth)
    Drug ClassesDiagnostic Agent, Helicobactor Pylori, Breath Test
    Active IngredientUrea, c-14
    Dosage FormCapsule
    RouteOral
    Strength1uci
    Market StatusPrescription
    CompanyAvent

    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.