Urea 13C - USP Grade
A grade designed for projects subject to pharmaceutical requirements
Urea (13C) is an isotopically labeled organic compound that functions as a substrate in metabolic labeling preparations and as a quantitation standard in sample tests. It is most widely known as the substrate used in the 13C-urea breath test (UBT), the reference non-invasive method for diagnosing Helicobacter pylori infection.
Non-radioactive
USP monograph aligned
Why Choose a USP-Grade Substrate
Reagents labeled with 13C behave chemically similar to their unlabeled counterparts, so they do not typically present biological concerns or bias. Another important benefit of using carbon-13 is that it is a stable isotope of carbon, eliminating the challenges of radioactivity associated with the older carbon-14 (14C) urea breath test. As a result, the 13C UBT has been demonstrated to be safe for use with children, pregnant women, and repeat patients, broadening patient care where radiation exposure would otherwise be a limiting factor.
For applications requiring a pharmaceutical-grade level of quality, Eurisotop offers a 13C-urea grade compliant with applicable USP requirements. The United States Pharmacopeia notably maintains a dedicated Urea C 13 monograph, along with a corresponding USP Reference Standard. This grade is intended for customers seeking 13C-urea with a level of characterization and control suited to pharmaceutical and regulated projects — designed to bring greater control and confidence to your development work.
🔬 Supporting rising global demand
As the global leader in 13C and 13C-urea production, Cambridge Isotope Laboratories continues to expand its manufacturing capacity — notably through its North Star project — to ensure a consistent, regulatory-compliant supply of 13C urea for diagnostic needs worldwide.
USP Grade Specifications
Tested per CIL internal methods and USP elemental impurity limits, for customers requiring documentation aligned with US Pharmacopeia practice.
| Tests | Specification |
|---|---|
| C-13 Enrichment | ≥ 99% |
| ID Test B – Retention Time Match | Pass |
| ID Test A – FTIR | Conforms |
| Residue on Ignition | ≤ 0.1% |
| Elemental Impurities | Arsenic, As ≤ 80 ppm Cadmium, Cd ≤ 50 ppm Chromium, Cr ≤ 120 ppm Lead, Pb ≤ 50 ppm Mercury, Hg ≤ 40 ppm Nickel, Ni ≤ 200 ppm |
| Assay | 98.0% – 102.0% |
| Methyl Carbamate | ≤ 0.1% |
| Biuret | ≤ 0.1% |
| Bioburden | < 100 CFU/gram |
| Appearance | White, crystalline powder |
| 18O Isotopic Enrichment | < 15,0% atom |
Additional testing list : Cyanuric Acid, Triuret, Other Related Substances, Total Related Substances, Ethanol Insoluble Substances, Chloride, Sulfate, Ammonium Ion, Alkalinity, Clarity and Color of Solution, Solubility.
