Alanylglutaminsäure, CAS 13187-90-1, ist eine definierte dipeptidische Verunreinigung aus Alanin- und Glutaminsäureresten mit der Summenformel C8H14N2O5 und einer Molekülmasse von 218,21 g/mol. Sie wird typischerweise mit Nebenreaktionen der Peptidkupplung, unvollständiger Entschützung oder teilweisem Sequenzübertrag während der Synthese von Aminosäurederivaten und verwandten Wirkstoffen in Verbindung gebracht. Als polare Zwitterionen-Spezies besitzt sie eine geringe Flüchtigkeit und wird üblicherweise mittels LC-MS/MS oder HILIC gekoppelt an hochauflösende MS charakterisiert, ergänzt durch ionenaustauschende oder derivatisierende LC-Verfahren. Regulatorisch wird sie als prozessbedingte Verunreinigung und nicht als genotoxischer Hinweis bewertet.
References
Schiesel, Simone, et al. “Quantitative High-Performance Liquid Chromatography–Tandem Mass Spectrometry Impurity Profiling Methods for the Analysis of Parenteral Infusion Solutions for Amino Acid Supplementation Containing L-Alanyl-l-Glutamine.†Journal of Chromatography A, vol. 1259, Oct. 2012, pp. 111–20,  https://doi.org/10.1016/j.chroma.2012.01.020.
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