Journal of Pharmaceutical and Biomedical Analysis, volume 214, pages 114715
Isolation, synthesis, identification of new process-related impurities in evocalcet
Publication type: Journal Article
Publication date: 2022-05-01
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Impact factor: 3.4
ISSN: 07317085, 1873264X
Drug Discovery
Spectroscopy
Pharmaceutical Science
Clinical Biochemistry
Analytical Chemistry
Abstract
Evocalcet is a calcimimetic for the treatment of secondary hyperparathyroidism. In the preparation of evocalcet, eleven process-related impurities were detected in the reaction solution of the last step at levels of 0.05%- 2.50% by a new HPLC method. Ten impurities were separated from the enriched mother liquor and synthesized directly. These impurities were characterized and identified by HRMS and NMR spectra and then coinjected with commercial products to confirm their retention times in HPLC. The possible formation pathways and synthetic methods of ten process-related impurities ware discussed in detail.
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Yan H. et al. Isolation, synthesis, identification of new process-related impurities in evocalcet // Journal of Pharmaceutical and Biomedical Analysis. 2022. Vol. 214. p. 114715.
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Yan H., Wang Y., Yue Y., Li L., Shi X., Zhang K., Xue N. Isolation, synthesis, identification of new process-related impurities in evocalcet // Journal of Pharmaceutical and Biomedical Analysis. 2022. Vol. 214. p. 114715.
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TY - JOUR
DO - 10.1016/j.jpba.2022.114715
UR - https://doi.org/10.1016/j.jpba.2022.114715
TI - Isolation, synthesis, identification of new process-related impurities in evocalcet
T2 - Journal of Pharmaceutical and Biomedical Analysis
AU - Yan, H
AU - Wang, Y
AU - Yue, Y
AU - Li, L
AU - Shi, X
AU - Zhang, K
AU - Xue, N
PY - 2022
DA - 2022/05/01 00:00:00
PB - Elsevier
SP - 114715
VL - 214
SN - 0731-7085
SN - 1873-264X
ER -
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@article{2022,
author = {H Yan and Y Wang and Y Yue and L Li and X Shi and K Zhang and N Xue},
title = {Isolation, synthesis, identification of new process-related impurities in evocalcet},
journal = {Journal of Pharmaceutical and Biomedical Analysis},
year = {2022},
volume = {214},
publisher = {Elsevier},
month = {may},
url = {https://doi.org/10.1016/j.jpba.2022.114715},
pages = {114715},
doi = {10.1016/j.jpba.2022.114715}
}