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UREA-13C

UREA-13C structure

CAS No:
58069-82-2
Formula:
CH4N2O
Chemical Name:
UREA-13C
Synonyms:
UREA- 13C 99%;UREA (13C, 99%, 15N2, 98%);UREA-13C USP(CRM STANDARD);UREA (13C, 99%);Urea-13C - Research Grade;Urea-13C ,99 atom % 13C [99 atom % 13C];Urea C 13 (150 mg);Aquacare-13C
Categories:
Active Pharmaceutical Ingredients > Urinary System Drugs

Description

White Solid

((13)C)urea is a (13)C-modified compound that is urea in which the carbon is present as its (13)C isotope. It is a (13)C-modified compound and a one-carbon compound.|Urea 13C is a urea molecule radiolabelled with the non-radioactive element carbon-13. It is currently used for the Urea Breath Test (UBT) and is available as a rapid diagnostic test (marketed as Pranactin-Citric) for the detection of Helicobacter pylori infections. H pylori is a common stomach bacteria that has been linked to a variety of upper gastrointestinal disorders such as gastritis, gastric and peptic ulcers, stomach cancer, and gastric mucosa-associated lymphoid-tissue (MALT) lymphoma. The UBT is indicated to confirm H. pylori infection and to monitor post-treatment for its eradication. Radiolabelled urea is available in two forms as 13C and 14C. Both forms can be used within the Urea Breath Test, however some may prefer 13C as it is non-radioactive compared to 14C, which may be preferable in pregnant women and children. The Urea Breath Test is based on the ability of the H. pylori enzyme urease to cleave urea into ammonia and carbon dioxide. As the urease enzyme is not present in mammalian cells, the presence of urease (and the products of urea cleavage) in the stomach is evidence that H. pylori bacteria are present. To detect H. pylori, urea labeled with 13C 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 13CO2 is absorbed into the blood and exhaled in the breath. Exhaled breath samples can then be collected and measured for the presence of radioactivity.|Urea c-13 is a Helicobacter pylori Diagnostic.|Urea C-13 is a radiolabelled urea molecule used to diagnose stomach ulcers caused by Heliobacter pylori. In the presence of H. pylori, urea C-13 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.

UREA-13C Basic Attributes

Molecular Weight：

61.06

Exact Mass：

61.03570

UNII：

W6KX9E6D8X

NCI Thesaurus Code：

C47779

ATC Code：

V04CX|V - Various

HScode：

31021000

Characteristics

PSA：

69.1

XLogP3：

-2.11

Density：

1.3230 @ 20 deg C/4 deg C

Melting Point：

132-135 °C(lit.)

Boiling Point：

Decomposes

Refractive Index：

1.468

Water Solubility：

In water, 5.45X10+5 mg/l @ 25 deg C

Vapor Pressure：

1.2X10-5 mm Hg @ 25 deg C

Explosive limit：

Reacts with sodium hypochlorite or calcium hypochlorite to form the explosive nitrogen trichloride.

Safety Information

Transport codes：

NONH for all modes of transport

wgk germany：

Drug Information

Drug Indication：

Urea-13C is indicated for use in the qualitative detection of urease associated with Helicobacter pylori in the human stomach and as an aid in the initial diagnosis and post-treatment monitoring of Helicobacter pylori infection in adult patients. The test may be used for monitoring treatment if used at least four (4) weeks following completion of therapy. For these purposes, the system utilizes an Infrared Spectrophotometer for the measurement of the ratio of 13CO2 to 12CO2 in breath samples.|FDA Label|This medicinal product is for diagnostic use only.For in vivo diagnosis of gastroduodenal Helicobacter pylori (H. pylori) infection.|Helicobacter Test INFAI may be used for in vivo diagnosis of gastroduodenal Helicobacter pylori infection in:adults;adolescents, who are likely to have peptic ulcer disease.Helicobacter Test INFAI for children aged three to 11 years may be used for in vivo diagnosis of gastrduodenal Helicobacter pylori infection:for the evaluation of the success of eradication treatment, or;when invasive tests cannot be performed, or;when there are discordant results arising from invasive tests.This medicinal product is for diagnostic use only.|Pylori-Chek may be used for in vivo diagnosis of gastroduodenal Helicobacter pylori infection.

Mechanism of Action：

The Urea Breath Test is based on the ability of the H. pylori enzyme urease to cleave urea into ammonia and carbon dioxide. As the urease enzyme is not present in mammalian cells, the presence of urease (and the products of urea cleavage) in the stomach is evidence that H. pylori bacteria are present. To detect H. pylori, urea labeled with 13C 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 13CO2 is absorbed into the blood and exhaled in the breath. Exhaled breath samples can then be collected and measured for the presence of radioactivity.

UREA-13C Use and Manufacturing

Uses

Labelled Urea. Physiological regulator of nitrogen excretion in mammals; synthesized in the liver as an end-product of protein catabolism and excreted in urine. Also occurs normally in skin. Emollient; diuretic.

Use Classification：

Human drugs -> Pylobactell -> EMA Drug Category|Diagnostic agents -> Human pharmacotherapeutic group|Human drugs -> Helicobacter Test INFAI -> EMA Drug Category|Human drugs -> Pylori-Chek -> EMA Drug Category|Human Drugs -> FDA Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) -> Active Ingredients

Computed Properties

Molecular Weight:61.048
XLogP3:-1.4
Hydrogen Bond Donor Count:2
Hydrogen Bond Acceptor Count:1
Exact Mass:61.035717591
Monoisotopic Mass:61.035717591
Topological Polar Surface Area:69.1
Heavy Atom Count:4
Complexity:29
Isotope Atom Count:1
Covalently-Bonded Unit Count:1
Compound Is Canonicalized:Yes

Drug Function and Efficacy

For breath test diagnosis

This ingredient has been used in drugs with the following functions (note: it does not mean that the ingredient itself has the following health functions)

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Registered Holders

Cambridge Isotope Laboratories,Inc.

Japan
Active
Beijing Richen-Force Science & Technology Co., Ltd.

China
Active
Shenzhen CNNC Heidewe Biotechnology Co., Ltd. Tongcheng Branch

China
Active

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