Amiodarone EP Impurity F, すなわち Amiodarone Related Compound F は、CAS 147030-50-0 のヨウ素化ベンゾフラン系フェノキシ誘導体である。分子式 C19H17IO3、分子量 420.24 を有し、アミオダロンの合成過程および安定性評価において生じうる工程由来または分解由来の関連不純物に位置付けられる。芳香族エーテルおよびベンゾフラン骨格により逆相LCで保持されやすく、微量定量には通常 LC-MS/MS が必要であり、構造確認には高分解能MSやNMRが用いられる。規制上は、薬局方の不純物管理枠組みにおける特定関連物質として扱われる。
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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