心血管活性物质和药品中存在的杂质:药典视角——

Arvind Sharma, F. Ali, A. Prakash, R. K. Goyal
{"title":"心血管活性物质和药品中存在的杂质:药典视角——","authors":"Arvind Sharma, F. Ali, A. Prakash, R. K. Goyal","doi":"10.2174/2213240609666220728091253","DOIUrl":null,"url":null,"abstract":"\n\nThe quality of drugs is a major concern for drug regulatory authorities and other stakeholders across the globe. Recently, drug regulatory authorities across the globe are facing a challenge to control the purity of cardiovascular (CVS) drugs for human use, especially drugs from Angiotensin Receptor Blocker family such as Valsartan. The present article is an attempt to provide a comprehensive knowledge on how pharmacopeias across the world are playing a key role in ensuring the quality of active pharmaceutical ingredients (API) and finished pharmaceutical products (FPPs). The comprehensive information on pharmaceutical impurities, separation strategies, relevant regulatory guidelines to control impurities, and their acceptable limits particularly with respect to cardiovascular active drug substances and drug formulations for human use are focused in this article.\n","PeriodicalId":10826,"journal":{"name":"Current chromatography","volume":"92 1","pages":""},"PeriodicalIF":0.0000,"publicationDate":"2022-07-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Impurities present in cardiovascular active substances and medicinal products: A Pharmacopoeial perspective--\",\"authors\":\"Arvind Sharma, F. Ali, A. Prakash, R. K. Goyal\",\"doi\":\"10.2174/2213240609666220728091253\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"\\n\\nThe quality of drugs is a major concern for drug regulatory authorities and other stakeholders across the globe. Recently, drug regulatory authorities across the globe are facing a challenge to control the purity of cardiovascular (CVS) drugs for human use, especially drugs from Angiotensin Receptor Blocker family such as Valsartan. The present article is an attempt to provide a comprehensive knowledge on how pharmacopeias across the world are playing a key role in ensuring the quality of active pharmaceutical ingredients (API) and finished pharmaceutical products (FPPs). The comprehensive information on pharmaceutical impurities, separation strategies, relevant regulatory guidelines to control impurities, and their acceptable limits particularly with respect to cardiovascular active drug substances and drug formulations for human use are focused in this article.\\n\",\"PeriodicalId\":10826,\"journal\":{\"name\":\"Current chromatography\",\"volume\":\"92 1\",\"pages\":\"\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2022-07-28\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Current chromatography\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.2174/2213240609666220728091253\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Current chromatography","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.2174/2213240609666220728091253","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 0

摘要

药品质量是全球药品监管当局和其他利益攸关方关注的主要问题。近年来,全球药物监管部门面临着控制人用心血管(CVS)药物纯度的挑战,特别是血管紧张素受体阻滞剂家族药物,如缬沙坦。本文试图提供关于世界各地药典如何在确保活性药物成分(API)和成品药物(FPPs)质量方面发挥关键作用的全面知识。本文重点介绍了药物杂质的综合信息、分离策略、控制杂质的相关监管指南,以及它们的可接受限度,特别是关于心血管活性原料药和人用药物制剂。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Impurities present in cardiovascular active substances and medicinal products: A Pharmacopoeial perspective--
The quality of drugs is a major concern for drug regulatory authorities and other stakeholders across the globe. Recently, drug regulatory authorities across the globe are facing a challenge to control the purity of cardiovascular (CVS) drugs for human use, especially drugs from Angiotensin Receptor Blocker family such as Valsartan. The present article is an attempt to provide a comprehensive knowledge on how pharmacopeias across the world are playing a key role in ensuring the quality of active pharmaceutical ingredients (API) and finished pharmaceutical products (FPPs). The comprehensive information on pharmaceutical impurities, separation strategies, relevant regulatory guidelines to control impurities, and their acceptable limits particularly with respect to cardiovascular active drug substances and drug formulations for human use are focused in this article.
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
自引率
0.00%
发文量
0
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
确定
请完成安全验证×
copy
已复制链接
快去分享给好友吧!
我知道了
右上角分享
点击右上角分享
0
联系我们:info@booksci.cn Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。 Copyright © 2023 布克学术 All rights reserved.
京ICP备2023020795号-1
ghs 京公网安备 11010802042870号
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术官方微信