Impurities present in cardiovascular active substances and medicinal products: A Pharmacopoeial perspective--

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 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.