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Current Chromatography

Author(s): Arvind K. Sharma*, Faraat Ali*, Anuj Prakash and Ramesh K. Goyal

DOI: 10.2174/2213240609666220728091253

Cite As
Impurities Present in Cardiovascular Active Substances and Medicinal Products: A Pharmacopoeial Perspective

Article ID: e280722207051 Pages: 15

  • * (Excluding Mailing and Handling)

Abstract

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 in controlling the purity of cardiovascular (CVS) drugs for human use, especially drugs from the Angiotensin Receptor Blocker family, such as Valsartan. The present article aims to provide comprehensive knowledge on how pharmacopeias worldwide play a key role in ensuring the quality of active pharmaceutical ingredients (API) and finished pharmaceutical products (FPPs). In this article, the focus is on comprehensive information regarding 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.

Keywords: Pharmaceutical sciences, pharmacopoeia, cardiovascular drugs, pharmaceutical impurities, NDMA, API.

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