Urea 13C
The reference substrate for the 13C-Urea Breath Test and non-invasive metabolic diagnostics
Urea-13C is the gold-standard substrate for the non-invasive detection of Helicobacter pylori infection. Ingested by the patient, it is hydrolyzed by bacterial urease into ammonia and isotopically labeled 13CO2, which is exhaled in the breath and measured — without needles, radiation, or invasive sampling.
The 13C-Urea Breath Test (UBT) exploits a simple principle: H. pylori is one of the only organisms able to colonize the acidic stomach, thanks to its abundant urease activity. When labeled urea is ingested, this urease rapidly hydrolyzes it into ammonia and 13C-labeled carbon dioxide, which diffuses into the blood and is excreted by the lungs. An increase in the 13CO2/12CO2 ratio in the breath — measured by isotope ratio mass spectrometry (IRMS), NDIRS, or LARA — indicates active infection.
Because carbon-13 is a stable, non-radioactive isotope, the test is safe for repeated use in children and women of childbearing age, and samples can be shipped by post or courier to remote analysis centers. The UBT is used both for the initial diagnosis of H. pylori and to confirm eradication after treatment, and remains the only non-invasive breath test currently approved for this indication.
Urea-13C Expertise That Makes the Difference
EURISO-TOP is one of the historical manufacturers of Urea-13C. Since the 1990s, we have been producing Urea-13C and supporting customers involved in breath test, analytical and pharmaceutical applications.
Our expertise was built over nearly three decades through manufacturing campaigns, analytical testing, quality control activities and continuous process improvements. This accumulated experience allows us to deliver reliable Urea-13C products and support a wide range of applications, from research projects to pharmaceutical environments.
Nearly 35 Years of Experience
Benefit from decades of manufacturing know-how dedicated specifically to Urea-13C production, purification and analytical characterization.
Manufacturing & Quality Expertise
Our teams master critical production steps, analytical testing methods and quality controls to ensure reproducible product quality.
A Solution for Every Development Stage
From research and feasibility studies to pharmaceutical projects, select the level of quality and documentation that matches your requirements.
Why Experience Matters
Manufacturing carbon-13 labelled compounds is not only about applying a chemical process. Product quality depends on process control, purification expertise, analytical characterization and batch-to-batch consistency.
Our long-standing experience with Urea-13C allows us to:
- Control critical manufacturing steps
- Perform adapted analytical characterization
- Maintain consistent product quality
- Identify and address production challenges efficiently
- Support customer-specific requirements
- Provide documentation adapted to different quality environments
When selecting Urea-13C, you are not only selecting a product. You are selecting the experience of the manufacturer behind it.
Grades & Specifications
Urea-13C is available in three grades, each backed by full analytical documentation and Certificates of Analysis, so you can select the level of regulatory support that matches your application.
Explore Our Urea-13C range
Three Grades for Three Levels of Requirements
A project may start with a few grams for feasibility studies and evolve toward analytical, quality or regulatory requirements. Our Urea-13C portfolio allows you to select the level of quality appropriate to your current development stage while benefiting from the same manufacturing expertise.
USP Grade
Applications requiring USP-oriented analytical documentation and support.
UBT Grade
Projects operating within pharmaceutical environments and breath test applications.
Reagent Grade
Research, analytical studies, method development and R&D projects.
Urea-13C Grades at a Glance
Compare our three Urea-13C grades and select the most appropriate level of analytical and regulatory support for your application.
| Comparison | USP Grade | UBT Grade | Reagent Grade |
|---|---|---|---|
| Recommended application | Applications requiring documentation aligned with USP practice | Urea Breath Test kit manufacturing | Research requiring high chemical purity |
| Testing basis | CIL internal methods and USP elemental impurity limits | Ph. Eur. monograph 0743 plus EURISO-TOP additional tests | CIL internal methods |
| Isotopic enrichment | ≥ 99% 13C | ≥ 99% 13C | ≥ 99% 13C |
| Assay | 98.0% – 102.0% | 98.5% – 101.5% | ≥ 98.0% |
| Additional testing | Biuret, Bioburden, Cyanuric Acid, Triuret, Other Related Substances, Total Related Substances, Ethanol Insoluble Substances, Chloride, Sulfate, Ammonium Ion, Alkalinity, Clarity and Color of Solution, Solubility | Solubility, Water Content, Chemical Purity by NMR, Pyrogenicity, Residual Solvents | - |
| Optional testing | 18O Isotopic Enrichment | 18O Isotopic Enrichment | - |
| Key benefit | USP-aligned analytical documentation | Designed for breath test applications | A lower price for non-pharmaceutical applications |
This table provides a simplified comparison. Complete specifications and analytical documentation are available upon request.
For any questions regarding our products, or to request an additional detail, please contact us.
