Amiodarone EP Impurity F, also designated Amiodarone Related Compound F, is the iodinated benzofuran phenoxy derivative identified by CAS 147030-50-0. With molecular formula C19H17IO3 and molecular weight 420.24, it represents a structurally related process or degradation impurity within the amiodarone synthetic and stability profile. Its aromatic ether and benzofuran functionality support reversed-phase LC behavior, while trace-level assessment typically requires LC-MS/MS and, where definitive structural confirmation is needed, high-resolution MS or NMR. In regulatory characterization, it is treated as a specified related substance under pharmacopeial impurity control frameworks rather than as a simple excipient-related trace constituent.
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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