Levofloxacin EP Impurity GはLevofloxacin Related Compound E 塩酸塩とも呼ばれる、明確に規定されたフルオロキノロン関連不純物であり、CAS 1346603-62-0、分子式 C16H19ClFN3O4、分子量 371.79 g/mol を有する。塩素化されたプロトン化構造は、レボフロキサシン原料の合成または結晶化過程で生じる工程由来、あるいは塩形成に関連した誘導体であることを示唆する。薬局方および規制上の文脈では、この種の関連物質は痕跡レベル不純物として評価され、通常はLC-MS/MSおよび高分解能LC-UVで解析し、必要に応じてNMRで確認する。定量には、類縁キノロン分解物やエピマーとの高い分離能が要求される。
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