Diclofenac Alcohol; Diclofenac Related Compound B; 2-[(2, 6-Dichlorophenyl)amino]benzenemethanol; [2-[(2, 6-Dichlorophenyl)
説明
Diclofenac EP Impurity C は、Diclofenac Related Compound C または Diclofenac Alcohol Analog とも呼ばれ、ジクロフェナクの還元アルコール体に相当するベンジヒドロール型不純物である。CAS 27204-57-5、分子式 C13H11Cl2NO、分子量 268.14 g/mol。過還元、あるいはカルボン酸官能基に関与する合成上および代謝上の副経路により生成し得る。ニトロソアミンではないが、構造的に関連する工程由来不純物として、ICH の不純物評価原則に基づく管理が必要である。微量定量には通常、LC-MS/MS、LC-HRMS、ならびに直交的 HPLC が用いられ、UV 検出のみでは同定が不十分なことが多い。
References
Lu, Yuqing, et al. “PEI-Modified Core-Shell/Bead-like Amino Silica Enhanced Poly (Vinyl Alcohol)/Chitosan for Diclofenac Sodium Efficient Adsorption.†Carbohydrate Polymers, vol. 229, Feb. 2020, p. 115459, https://doi.org/10.1016/j.carbpol.2019.115459.?Tang, Wei. “The Metabolism of Diclofenac – Enzymology and Toxicology Perspectives.†Current Drug Metabolism, vol. 4, no. 4, Aug. 2003, pp. 319–29, https://doi.org/10.2174/1389200033489398.?
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