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15N ammonium chloride is a non-radioactive, stable isotope tracer developed by Unicyte AG for the diagnostic assessment of ureagenesis capacity in patients with urea cycle disorders (UCDs). The agent consists of ammonium chloride labeled with the stable nitrogen-15 isotope. Upon oral or intravenous administration, the [15N]ammonium ion enters the urea cycle in the liver, where it is enzymatically processed by carbamoyl phosphate synthetase 1 (CPS1), ornithine transcarbamylase (OTC), argininosuccinate synthase (ASS), and argininosuccinate lyase (ASL) to produce [15N]labeled urea. The enrichment of [15N]urea in plasma or dried blood spots is then measured using high-resolution mass spectrometry (UHPLC-HRMS) to quantify the patient's functional urea production capacity. This tracer is primarily used in clinical research to validate ureagenesis as a biomarker for evaluating the efficacy of novel treatments, such as liver stem cell therapies, in neonates and infants with UCDs.
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