Abacavir EP Impurity A, CAS 136470-79-6, ist eine strukturell definierte, prozessbedingte Verunreinigung im Zusammenhang mit dem Nukleosid-RT-Inhibitor Abacavir. Mit der Summenformel C14H18N6O und einer molaren Masse von 286,33 g/mol handelt es sich um ein heteroaromatisches, aminisches Analogon, dessen Auftreten typischerweise auf Synthesezwischenprodukte oder Nebenreaktionen beim Aufbau des triazinhaltigen Gerüstes zurückgeführt wird. Für Strukturzuordnung und Spurenquantifizierung sind üblicherweise LC-MS/MS, hochauflösende LC-MS sowie orthogonale HPLC- oder UPLC-Verfahren mit UV-Detektion erforderlich. Im regulatorischen Kontext wird die Substanz im Rahmen der Verwandtstoffkontrolle und gegebenenfalls hinsichtlich mutagener Relevanz nach ICH M7 bewertet.
References
Kurmi, Moolchand, et al. “Stability Behaviour of Antiretroviral Drugs and Their Combinations. 5: Characterization of Novel Degradation Products of Abacavir Sulfate by Mass and Nuclear Magnetic Resonance Spectrometry.” Journal of Pharmaceutical and Biomedical Analysis, vol. 134, Feb. 2017, pp. 372–84, https://doi.org/10.1016/j.jpba.2016.10.019. ?Vukkum, Pallavi. “Stress Degradation Behavior of Abacavir Sulfate and Development of a Suitable Stability-Indicating UHPLC Method for the Determination
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