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A Simple and Accurate Method for the Determination of Related Substances in Coenzyme Q10 Soft Capsules

As a new dosage form, coenzyme Q10 (Co-Q10) soft capsules are easily absorbed and utilized by the human body. Co-Q10 soft capsules can effectively improve the bioavailability and reduce medical costs for patients. A main concern about Co-Q10 as an active pharmaceutical ingredient (API) is how to con...

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Autores principales: Bao, Kangde, Zhang, Chaojun, Xie, Shenggu, Feng, Guifang, Liao, Shiyu, Cai, Lietao, He, Jiajia, Guo, Yueqin, Jiang, Chengxi
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6540194/
https://www.ncbi.nlm.nih.gov/pubmed/31067711
http://dx.doi.org/10.3390/molecules24091767
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author Bao, Kangde
Zhang, Chaojun
Xie, Shenggu
Feng, Guifang
Liao, Shiyu
Cai, Lietao
He, Jiajia
Guo, Yueqin
Jiang, Chengxi
author_facet Bao, Kangde
Zhang, Chaojun
Xie, Shenggu
Feng, Guifang
Liao, Shiyu
Cai, Lietao
He, Jiajia
Guo, Yueqin
Jiang, Chengxi
author_sort Bao, Kangde
collection PubMed
description As a new dosage form, coenzyme Q10 (Co-Q10) soft capsules are easily absorbed and utilized by the human body. Co-Q10 soft capsules can effectively improve the bioavailability and reduce medical costs for patients. A main concern about Co-Q10 as an active pharmaceutical ingredient (API) is how to control the total quantity of related substances. In this article, according to the degradation pattern of the API, the most easily degradable impurity (impurity X) in the sample was prepared and its chemical structure was determined. Furthermore, a simple and accurate method was developed for the determination of related substances and to avert the interference of excipient ingredients in Co-Q10 soft capsules. The approach was validated adequately and the primary impurity X was confirmed accurately. The limit of total quantity of related substances (less than 1%) could be revised to the level of specific impurity X being no more than 0.5%, in this effective quality control method of Co-Q10 soft capsules. The revised level is suggested to be included in the corresponding standard of the supplement taken from the Pharmacopoeia of the People’s Republic of China (2015 edition). This can provide a feasible method for the relevant enterprises and regulatory authorities to control the related substances of coenzyme Q10 soft capsules.
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spelling pubmed-65401942019-05-31 A Simple and Accurate Method for the Determination of Related Substances in Coenzyme Q10 Soft Capsules Bao, Kangde Zhang, Chaojun Xie, Shenggu Feng, Guifang Liao, Shiyu Cai, Lietao He, Jiajia Guo, Yueqin Jiang, Chengxi Molecules Article As a new dosage form, coenzyme Q10 (Co-Q10) soft capsules are easily absorbed and utilized by the human body. Co-Q10 soft capsules can effectively improve the bioavailability and reduce medical costs for patients. A main concern about Co-Q10 as an active pharmaceutical ingredient (API) is how to control the total quantity of related substances. In this article, according to the degradation pattern of the API, the most easily degradable impurity (impurity X) in the sample was prepared and its chemical structure was determined. Furthermore, a simple and accurate method was developed for the determination of related substances and to avert the interference of excipient ingredients in Co-Q10 soft capsules. The approach was validated adequately and the primary impurity X was confirmed accurately. The limit of total quantity of related substances (less than 1%) could be revised to the level of specific impurity X being no more than 0.5%, in this effective quality control method of Co-Q10 soft capsules. The revised level is suggested to be included in the corresponding standard of the supplement taken from the Pharmacopoeia of the People’s Republic of China (2015 edition). This can provide a feasible method for the relevant enterprises and regulatory authorities to control the related substances of coenzyme Q10 soft capsules. MDPI 2019-05-07 /pmc/articles/PMC6540194/ /pubmed/31067711 http://dx.doi.org/10.3390/molecules24091767 Text en © 2019 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (http://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Bao, Kangde
Zhang, Chaojun
Xie, Shenggu
Feng, Guifang
Liao, Shiyu
Cai, Lietao
He, Jiajia
Guo, Yueqin
Jiang, Chengxi
A Simple and Accurate Method for the Determination of Related Substances in Coenzyme Q10 Soft Capsules
title A Simple and Accurate Method for the Determination of Related Substances in Coenzyme Q10 Soft Capsules
title_full A Simple and Accurate Method for the Determination of Related Substances in Coenzyme Q10 Soft Capsules
title_fullStr A Simple and Accurate Method for the Determination of Related Substances in Coenzyme Q10 Soft Capsules
title_full_unstemmed A Simple and Accurate Method for the Determination of Related Substances in Coenzyme Q10 Soft Capsules
title_short A Simple and Accurate Method for the Determination of Related Substances in Coenzyme Q10 Soft Capsules
title_sort simple and accurate method for the determination of related substances in coenzyme q10 soft capsules
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6540194/
https://www.ncbi.nlm.nih.gov/pubmed/31067711
http://dx.doi.org/10.3390/molecules24091767
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