Case History-The Control of Impurities-A Critical Issue to The Active Pharmaceutical Ingredient

Abstract

The ICH guidelines on impurity have clearly defined the levels of toxic impurities and have become benchmark in establishing impurities in pharmaceutical drug products. The present article summarizes the concept of impurity profiling and presents a case study on impurity profiling of quantification of active pharmaceutical ingredient and impurities in sildenafil citrate purchased via internet and its relative outcomes.