Synthesis and quality control of ~(13)C-enriched urea for Helicobacter pylori (HP) diagnosis [Síntese e controle de qualidade da ureia enriquecida em ~(13)C para diagnóstico da helicobacter pylori (HP)]

摘要

The aim of the study was to synthesize the urea (~(13)CO(NH _2)_2), with 99% 13C atoms, and to perform a quality analysis for the diagnosis (breath test) of Helicobacter pylori. Furthermore, the process was submitted to economic analysis. The reaction was performed in a stainless steel reactor, lined with polytetrafuoroethylene, under low pressure and temperature. The synthesis method was shown to be appropriate (2.35 g; 81.9% yield), evidenced by physico-chemical and microbiological results, according to Brazilian legislation. The production and diagnosis costs were competitive compared with national and international market values, rendering this a valuable tool in clinical medicine.