ArticleAdvances in pharmacological and pharmaceutical sciences2024
Identification, Synthesis, and Characterization of N-Formyl Mirabegron: A New Degradation Product Formed by Formic Acid Impurity in Pharmaceutical Excipients.
Article in Advances in pharmacological and pharmaceutical sciences, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
This study demonstrated the impact of formic acid (FAc), a common reactive impurity in pharmaceutical excipients, on the stability of mirabegron (MB). The investigation of MB-excipient compatibility tests revealed the formation of a new degradation product, FAc-DP, at 0.2% after 7 days of isothermal stress at 55°C. FAc-DP was synthesized and characterized as N-formyl MB using liquid chromatography-mass spectrometry (LC-MS) and both 1D and 2D nuclear magnetic resonance spectroscopy (NMR).
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