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Updated: Feb 5, 2026

Formation of Dispersible Taohong Siwu Tablets
Published on: February 3, 2023
Identification and structure elucidation of a new degradation impurity in the multi-component tablets of amlodipine
Petr Gibala1, Michal Douša1, Aneta Kalužíková2
1Zentiva, k.s. Praha, U Kabelovny 130, 102 37 Praha 10, Czech Republic.
Abstract:
New unknown impurity at m/z 421.15 was observed during the accelerated stability analysis (40 °C/75% relative humidity) in the multi-component tablets of amlodipine besylate by reversed-phase ultra-high performance liquid chromatography-mass spectrometry (UHPLC-MS). UHPLC-MS and nuclear magnetic resonance (NMR) techniques were employed to identify and fully characterize the degradation compound. The degradation product was unambiguously identified as 3-ethyl 5-methyl 4-(2-chlorophenyl)-6-methyl-2-(morpholin-2-yl)-1,4-dihydropyridine-3,5-dicarboxylate and mechanism of its formation was proposed. It was confirmed that the degradation product was formed by the reaction of amlodipine with formaldehyde originating from the excipients present in the dosage form.
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