Urea 13C - UBT Grade
A grade designed for the requirements of the European pharmaceutical market
Our Ph. Eur. grade is developed and controlled in line with the relevant requirements of the European Pharmacopoeia, notably those of monograph 0743 – Urea. It is intended for customers seeking 13C-urea with a level of quality and control suited to a European pharmaceutical environment.
The European Pharmacopoeia regularly revises its monographs to reflect analytical advances and current quality control requirements. Monograph 0743 Urea is currently undergoing revision work, and a dedicated Urea 13C monograph project is being carried out in collaboration with the EDQM (European Directorate for the Quality of Medicines & HealthCare). A quality approach suited to projects where compliance, traceability, and documentation are essential.
The urea breath test (UBT) is used to detect Helicobacter pylori, a bacterium linked to gastritis and peptic ulcers and affecting over half of the global population. It measures exhaled 13C carbon dioxide after ingestion of 13C-labeled urea: a patient first breathes into a collection device to establish a baseline, then drinks a solution containing 13C urea, and after 15 to 30 minutes breathes again into a second device for comparison.
Ph. Eur. monograph 0743
Pyrogenicity tested
Why the UBT Grade Matters
The 13C UBT is considered the gold standard noninvasive test for H. pylori infection in many settings, enabling the direct functional detection of metabolically active infection to quickly determine the need for treatment or the response to treatment. Manufactured to Ph. Eur. monograph 0743 "Urea" plus additional EURISO-TOP testing, including pyrogenicity, this grade is the choice of reference for breath test kit manufacturers who require consistent quality and traceability across production batches.
UBT Grade Specifications
Manufactured to Ph. Eur. monograph 0743 "Urea" plus EURISO-TOP additional testing, including pyrogenicity — the grade of choice for breath test kit manufacturers.
| Tests | Specifications |
|---|---|
| Appearance1 | White or almost white, crystalline powder or transparent crystals, slightly hygroscopic |
| Solubility1 | Very soluble in water, soluble in ethanol (96%), practically insoluble in methylene chloride |
| A. Melting point1 (2.2.14) | 132 – 135°C |
| B. FT-IR Spectrometry1 | I.R. spectrum identical to urea CRS except two absorption bands |
| Appearance of the solution1 | Clear, colorless |
| Alkalinity1 | Red to orange |
| Biuret1 | ≤ 0.1% |
| Ammonium1 (2.4.1) | ≤ 500 ppm |
| Loss on drying1 (2.2.32) | ≤ 1.0% |
| Sulfated ashes1 (2.4.14) | ≤ 0.1% |
| Assay1 | 98.5% – 101.5% |
| Chemical purity / Structure2 (1H NMR, 13C NMR) | Conforms to reference |
| Isotopic enrichment2 (GC/MS) | ≥ 99.0% 13C |
| Water content2 (2.5.12, method A) | ≤ 1.0% |
| Heavy Metals2 (2.4.8, method A) | ≤ 10 ppm |
| Pyrogenicity2 (2.6.14, method A) | ≤ 0.125 EU/mg |
| Residual solvents2 (G.C., HeadSpace): Methanol / Ethanol / Diethyl ether | < 3000 ppm / < 5000 ppm / < 5000 ppm |
| 18O Isotopic Enrichment2 | < 15,0% atom 18O |
1Tests as per monograph No. 0743 "Urea" of the Ph. Eur., current edition. 2EURISO-TOP additional test.
