Structure Elucidation and Mechanistic Study of a New Dimer Impurity in Mirabegron Extended-Release Tablets

Lin, Xinghua; Hao, Gugu; Xu, Guobin; Sun, Fuzhou; Xin, Libo; Wu, S. X.; Wang, Zhongqing; You, Jinsong; Huang, Fangfang; Song, Xue‐Zhi

doi:10.1007/s10337-022-04231-2

Chromatographia

2022

DOI: 10.1007/s10337-022-04231-2

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Structure Elucidation and Mechanistic Study of a New Dimer Impurity in Mirabegron Extended-Release Tablets

Xinghua Lin

Gugu Hao

Guobin Xu

et al.

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Cited by 2 publications

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“…In addition, it is possible to obtain more complete chemical profiles of complex biological samples in a very short time (Xiong et al, 2021). NMR can be applied to all hydrogen-containing compounds, it is easy to operate, and precise and accurate molecular structures can be obtained without damaging the sample (Lin et al, 2023). Therefore, untargeted metabolomics based on 1 H-NMR and UPLC-QTOF-MS could more comprehensively search differential metabolites associated with GIOP in feces and improve the accuracy and reliability of the identification of metabolites.…”

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confidence: 99%

An integrated fecal metabolomic based on ¹H‐NMR and UPLC‐QTOF‐MS revealed the preventive mechanism of Gushudan on glucocorticoid‐induced osteoporotic rats

Xin

Liu

Lou

et al. 2023

Biomedical Chromatography

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Gushudan (GSD) has the effect of strengthening bones and nourishing kidneys. However, its specific intervention mechanism still remains unclear. In this study, to investigate the pathogenesis of glucocorticoid‐induced osteoporosis (GIOP) and the preventive mechanism of GSD on GIOP, fecal metabolomics based on 1H‐NMR and ultra‐high‐performance liquid chromatography‐quadrupole time‐of‐flight‐mass spectrometry method was established. The changes in endogenous metabolites and the relevant metabolic pathways in the control group, model group, and GSD treatment group were investigated via multivariate statistical analysis. As a result, a total of 39 differential metabolites were identified. Of these, 22 metabolites, such as L‐methionine, guanine, and sphingosine, were newly discovered as differential metabolites of GIOP. Amino acid metabolism, energy metabolism, intestinal flora metabolism, and lipid metabolism were significantly changed in the fecal profiles of GIOP rats, and GSD could play an anti‐osteoporosis role by regulating these metabolic pathways. Finally, compared with our previous study of the GSD to prevent kidney yang deficiency syndrome, this study suggested that there were some identical differential metabolites and metabolic pathways. It showed that there was some correlation among the metabolic profiles of the intestine, kidney, and bone in GIOP rats. Therefore, this study offered new insights into the in‐depth understanding of the pathogenesis of GIOP and the intervention mechanism of GSD.

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confidence: 99%

An integrated fecal metabolomic based on ¹H‐NMR and UPLC‐QTOF‐MS revealed the preventive mechanism of Gushudan on glucocorticoid‐induced osteoporotic rats

Xin

Liu

Lou

et al. 2023

Biomedical Chromatography

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

Daoud Agha Dit Daoudy,

Al-Khayat,

Abo Chameh

et al. 2024

Advances in Pharmacological and Pharmaceutical Sciences

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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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Structure Elucidation and Mechanistic Study of a New Dimer Impurity in Mirabegron Extended-Release Tablets

Cited by 2 publications

References 19 publications

An integrated fecal metabolomic based on ¹H‐NMR and UPLC‐QTOF‐MS revealed the preventive mechanism of Gushudan on glucocorticoid‐induced osteoporotic rats

An integrated fecal metabolomic based on ¹H‐NMR and UPLC‐QTOF‐MS revealed the preventive mechanism of Gushudan on glucocorticoid‐induced osteoporotic rats

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

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Structure Elucidation and Mechanistic Study of a New Dimer Impurity in Mirabegron Extended-Release Tablets

Cited by 2 publications

References 19 publications

An integrated fecal metabolomic based on 1H‐NMR and UPLC‐QTOF‐MS revealed the preventive mechanism of Gushudan on glucocorticoid‐induced osteoporotic rats

An integrated fecal metabolomic based on 1H‐NMR and UPLC‐QTOF‐MS revealed the preventive mechanism of Gushudan on glucocorticoid‐induced osteoporotic rats

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

Contact Info

Product

Resources

About

An integrated fecal metabolomic based on ¹H‐NMR and UPLC‐QTOF‐MS revealed the preventive mechanism of Gushudan on glucocorticoid‐induced osteoporotic rats

An integrated fecal metabolomic based on ¹H‐NMR and UPLC‐QTOF‐MS revealed the preventive mechanism of Gushudan on glucocorticoid‐induced osteoporotic rats