- Book学术

发布求助

文献互助智能选刊最新文献

IF 4.3 3区医学 Q1 PHARMACOLOGY & PHARMACY

European Journal of Pharmaceutical Sciences Pub Date : 2025-03-30 DOI:10.1016/j.ejps.2025.107083

Y. Polak , C.E.M. Hollak , E.L. Swart , E.M. Kemper

{"title":"Quality assessment of cholic acid as an active pharmaceutical ingredient: Analytical method and results","authors":"Y. Polak , C.E.M. Hollak , E.L. Swart , E.M. Kemper","doi":"10.1016/j.ejps.2025.107083","DOIUrl":null,"url":null,"abstract":"<div><div>Commercial cholic acid (CA) treatment is currently unavailable to Dutch patients with a bile acid synthesis defect. CA treatment has been hypothesized to correct the biochemical abnormalities associated with these disorders and potentially slowing down disease progression. To address this need, the hospital pharmacy of Amsterdam University Medical Center developed CA capsules for use in a clinical trial in The Netherlands. Challenges arose during the quality control of CA active pharmaceutical ingredient (API) as no specific substance monograph is available in the European Pharmacopoeia or other effective pharmacopoeias. In this article, we share an analytical method validated for testing the purity of CA and present the results of its quality control, offering practical guidance for ensuring adequate quality control of CA.</div><div>Pharmaceutical quality tests were performed on four batches of CA following the guidance given in the European Pharmacopoeia general monograph on substances for pharmaceutical use. The results confirm the suitability of our analytical method for CA quality control and demonstrate that the CA meets the high-quality standards required for pharmaceutical use.</div></div>","PeriodicalId":12018,"journal":{"name":"European Journal of Pharmaceutical Sciences","volume":"209 ","pages":"Article 107083"},"PeriodicalIF":4.3000,"publicationDate":"2025-03-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"European Journal of Pharmaceutical Sciences","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S092809872500082X","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"PHARMACOLOGY & PHARMACY","Score":null,"Total":0}

引用次数: 0

摘要

目前，有胆汁酸合成缺陷的荷兰患者无法获得商业胆酸（CA）治疗。据推测，CA 治疗可纠正与这些疾病相关的生化异常，并有可能减缓疾病的进展。为了满足这一需求，阿姆斯特丹大学医疗中心的医院药房开发了 CA 胶囊，用于荷兰的一项临床试验。由于《欧洲药典》或其他有效的药典中没有专门的物质专论，因此在 CA 活性药物成分 (API) 的质量控制过程中遇到了挑战。在这篇文章中，我们分享了一种经过验证的用于检测 CA 纯度的分析方法，并介绍了其质量控制结果，为确保对 CA 进行适当的质量控制提供了实用指导。我们按照《欧洲药典》药用物质总论的指导，对四批 CA 进行了药用质量测试。结果证实了我们的分析方法适用于 CA 质量控制，并证明 CA 符合药用的高质量标准。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

Quality assessment of cholic acid as an active pharmaceutical ingredient: Analytical method and results

查看原文本刊更多论文

Quality assessment of cholic acid as an active pharmaceutical ingredient: Analytical method and results

Commercial cholic acid (CA) treatment is currently unavailable to Dutch patients with a bile acid synthesis defect. CA treatment has been hypothesized to correct the biochemical abnormalities associated with these disorders and potentially slowing down disease progression. To address this need, the hospital pharmacy of Amsterdam University Medical Center developed CA capsules for use in a clinical trial in The Netherlands. Challenges arose during the quality control of CA active pharmaceutical ingredient (API) as no specific substance monograph is available in the European Pharmacopoeia or other effective pharmacopoeias. In this article, we share an analytical method validated for testing the purity of CA and present the results of its quality control, offering practical guidance for ensuring adequate quality control of CA.

Pharmaceutical quality tests were performed on four batches of CA following the guidance given in the European Pharmacopoeia general monograph on substances for pharmaceutical use. The results confirm the suitability of our analytical method for CA quality control and demonstrate that the CA meets the high-quality standards required for pharmaceutical use.

求助全文

通过发布文献求助，成功后即可免费获取论文全文。去求助

来源期刊

European Journal of Pharmaceutical Sciences 医学-药学

CiteScore

9.60

自引率

2.20%

发文量

248

审稿时长

50 days

期刊介绍： The journal publishes research articles, review articles and scientific commentaries on all aspects of the pharmaceutical sciences with emphasis on conceptual novelty and scientific quality. The Editors welcome articles in this multidisciplinary field, with a focus on topics relevant for drug discovery and development. More specifically, the Journal publishes reports on medicinal chemistry, pharmacology, drug absorption and metabolism, pharmacokinetics and pharmacodynamics, pharmaceutical and biomedical analysis, drug delivery (including gene delivery), drug targeting, pharmaceutical technology, pharmaceutical biotechnology and clinical drug evaluation. The journal will typically not give priority to manuscripts focusing primarily on organic synthesis, natural products, adaptation of analytical approaches, or discussions pertaining to drug policy making. Scientific commentaries and review articles are generally by invitation only or by consent of the Editors. Proceedings of scientific meetings may be published as special issues or supplements to the Journal.