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
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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。
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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.
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