Identification, Synthesis, and Characterization of N-Formyl Mirabegron: A New Degradation Product Formed by Formic Acid Impurity in Pharmaceutical Excipients
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Researchers |
Bashir Daoud Agha Dit Daoudy, Mohammad Ammar Al-Khayat, Ghassan Abo Chameh and Mohammad Amer Al Mardini |
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Published in |
Advances in Pharmacological and Pharmaceutical Sciences, volume 2024, article ID 4971456, 10 pages, December 2024. |
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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). Key words: compatibility tests; formic acid; mirabegron; N-formyl mirabegron; pharmaceutical excipients; reactive impurities. |
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Link to full paper |
