Isolation, Identification, and Characterization of an Unknown Impurity in Lovastatin EP

An unknown impurity in the fermentation-based drug substance lovastatin at 0.52 RRT was observed invariably in all batches when analyzed by HPLC as per the PhEur monograph. This impurity was isolated from the impurity-enriched sample using reversed-phase preparative HPLC and characterized by using s...

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Autores principales: Belwal, Chandrakant, Goyal, Praveen Kumar, Balte, Anup, Kolhe, Sandeep, Chauhan, Kamlesh, Rawat, Ajay Singh, Vardhan, Anand
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Österreichische Apotheker-Verlagsgesellschaft 2014
Materias:
Research Article
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3951232/
https://www.ncbi.nlm.nih.gov/pubmed/24634841
http://dx.doi.org/10.3797/scipharm.1305-04
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author Belwal, Chandrakant
Goyal, Praveen Kumar
Balte, Anup
Kolhe, Sandeep
Chauhan, Kamlesh
Rawat, Ajay Singh
Vardhan, Anand
author_facet Belwal, Chandrakant
Goyal, Praveen Kumar
Balte, Anup
Kolhe, Sandeep
Chauhan, Kamlesh
Rawat, Ajay Singh
Vardhan, Anand
author_sort Belwal, Chandrakant
collection PubMed
description An unknown impurity in the fermentation-based drug substance lovastatin at 0.52 RRT was observed invariably in all batches when analyzed by HPLC as per the PhEur monograph. This impurity was isolated from the impurity-enriched sample using reversed-phase preparative HPLC and characterized by using spectroscopic (PMR, CMR, MASS, and UV) techniques as the structurally-related compound Monacolin-X, having the molecular formula C(24)H(34)O(6) and the chemical name 2-methyl-3-oxobutanoic acid 1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)ethyl]-1-naphthalenyl ester.
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spelling pubmed-39512322014-03-14 Isolation, Identification, and Characterization of an Unknown Impurity in Lovastatin EP Belwal, Chandrakant Goyal, Praveen Kumar Balte, Anup Kolhe, Sandeep Chauhan, Kamlesh Rawat, Ajay Singh Vardhan, Anand Sci Pharm Research Article An unknown impurity in the fermentation-based drug substance lovastatin at 0.52 RRT was observed invariably in all batches when analyzed by HPLC as per the PhEur monograph. This impurity was isolated from the impurity-enriched sample using reversed-phase preparative HPLC and characterized by using spectroscopic (PMR, CMR, MASS, and UV) techniques as the structurally-related compound Monacolin-X, having the molecular formula C(24)H(34)O(6) and the chemical name 2-methyl-3-oxobutanoic acid 1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)ethyl]-1-naphthalenyl ester. Österreichische Apotheker-Verlagsgesellschaft 2014 2013-07-01 /pmc/articles/PMC3951232/ /pubmed/24634841 http://dx.doi.org/10.3797/scipharm.1305-04 Text en © Belwal et al.; licensee Österreichische Apotheker-Verlagsgesellschaft m. b. H., Vienna, Austria. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/3.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Research Article
Belwal, Chandrakant
Goyal, Praveen Kumar
Balte, Anup
Kolhe, Sandeep
Chauhan, Kamlesh
Rawat, Ajay Singh
Vardhan, Anand
Isolation, Identification, and Characterization of an Unknown Impurity in Lovastatin EP
title Isolation, Identification, and Characterization of an Unknown Impurity in Lovastatin EP
title_full Isolation, Identification, and Characterization of an Unknown Impurity in Lovastatin EP
title_fullStr Isolation, Identification, and Characterization of an Unknown Impurity in Lovastatin EP
title_full_unstemmed Isolation, Identification, and Characterization of an Unknown Impurity in Lovastatin EP
title_short Isolation, Identification, and Characterization of an Unknown Impurity in Lovastatin EP
title_sort isolation, identification, and characterization of an unknown impurity in lovastatin ep
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3951232/
https://www.ncbi.nlm.nih.gov/pubmed/24634841
http://dx.doi.org/10.3797/scipharm.1305-04
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