Abacavir EP Impurity A, CAS 136470-79-6 は、ヌクレオシド系逆転写酵素阻害薬アバカビルに関連する構造既知のプロセス由来不純物である。分子式 C14H18N6O、分子量 286.33 g/mol のヘテロ芳香族アミノ化類縁体であり、その生成は通常、トリアジン含有骨格の合成中間体や副反応に起因すると解釈される。構造確認と微量定量には、LC-MS/MS、高分解能LC-MS、ならびにUV検出を用いるHPLCまたはUPLCの直交的手法が一般に必要となる。規制上は関連物質として管理され、該当する場合にはICH M7に基づく変異原性リスク評価の対象となる。
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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