Amiodarone Related Compound G / 1-Methoxy Amiodarone
説明
アミオダロンEP不純物Gは、Amiodarone Related Compound G または 1-Methoxy Amiodarone とも呼ばれる、ベンゾフラン系抗不整脈薬アミオダロンの構造既知の芳香族エーテル不純物である。CAS 1087223-70-8、分子式 C26H31I2NO4、分子量 675.34 g/mol を有し、親化合物のフェノール性酸素が O-メチル化された構造に相当する。この種の類縁体は、主として酸化分解よりも合成由来の副生成物または工程関連不純物として生じる。検出および定量には、ヨウ素置換体特有のイオン化挙動と近縁体との高いクロマトグラフィー近似性のため、LC-MS/MS および高分解能 LC-MS が通常必要であり、NMR や LC-UV が補助的に用いられる。
References
Karmarkar, S., et al. “Quality by Design (QbD) Based Development and Validation of an HPLC Method for Amiodarone Hydrochloride and Its Impurities in the Drug Substance.â€Â Journal of Pharmaceutical and Biomedical Analysis, vol. 100, Nov. 2014, pp. 167–74, https://doi.org/10.1016/j.jpba.2014.07.002.
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