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

Abstract

Abstract: The quality of drugs is a major concern for drug regulatory authorities and other stake-holders across the globe. Recently, drug regulatory authorities across the globe are facing a chal-lenge 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 ar-ticle, the focus is on comprehensive information regarding pharmaceutical impurities, separation strategies, relevant regulatory guidelines to control impurities, and their acceptable limits, particu-larly with respect to cardiovascular active drug substances and drug formulations for human use.