Urea C-13 API Manufacturers

General Description:

Urea C-13, identified by CAS number 58069-82-2, is a notable compound with significant therapeutic applications. 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.

Indications:

This drug is primarily indicated for: 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. Its use in specific medical scenarios underscores its importance in the therapeutic landscape.

Mechanism of Action:

Urea C-13 functions by: 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. This mechanism highlights the drug's role in inhibiting or promoting specific biological pathways, contributing to its therapeutic effects.

Classification:

Urea C-13 belongs to the class of organic compounds known as ureas. These are compounds containing two amine groups joined by a carbonyl (C=O) functional group, classified under the direct parent group Ureas. This compound is a part of the Organic compounds, falling under the Organic acids and derivatives superclass, and categorized within the Organic carbonic acids and derivatives class, specifically within the Ureas subclass.

Categories:

Urea C-13 is categorized under the following therapeutic classes: Diagnostic Agents, Helicobacter pylori Diagnostic. These classifications highlight the drug's diverse therapeutic applications and its importance in treating various conditions.