Identification, Synthesis, and Characterization of N-Formyl Mirabegron: A New Degradation Product Formed by Formic Acid Impurity in Pharmaceutical Excipients

Autor: Bashir Daoud Agha Dit Daoudy, Mohammad Ammar Al-Khayat, Ghassan Abo Chameh, Mohammad Amer Al Mardini
Jazyk: angličtina
Rok vydání: 2024
Předmět:
Zdroj: Advances in Pharmacological and Pharmaceutical Sciences, Vol 2024 (2024)
Druh dokumentu: article
ISSN: 2633-4690
DOI: 10.1155/adpp/4971456
Popis: 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).
Databáze: Directory of Open Access Journals
Nepřihlášeným uživatelům se plný text nezobrazuje