A Review on Significances of Impurity Profiling

Abstract

In pharmaceutical world, an impurity is considered as any other organic or inorganic material, besides the drug substance, or ingredients, that arise out of synthesis or unwanted chemicals that remains with API's. The impurity may arise either during formulation, or upon aging of both API's and formulated API's in medicines. Nowadays, the focus has been definitely shifted from the ‘purity profile ‘to ‘impurity profile’ (IMPs) that are present in the drug substance and degradation products (DP) including genotoxic impurities (GITs) in the finished pharmaceutical products. The presence of such superfluous impurities may affects the ADMET properties of drugs in human body. The control of impurities in formulated products and API's were regulated by different regulatory authorities like ICH, USFDA, FDA, Canadian Drug and Health Agency are emphasizing on the purity profile and the identification of impurities in API's. Thus enlightening the need of impurity profiling of drug substances or drug products in pharmaceutical research this review focuses on various analytical method and advances in the analytical techniques used for their identification as well as qualification of the impurities present in pharmaceutical products. There are different methods for detecting and characterizing the impurities with TLC, HPLC, HPTLC, etc. Impurity profiling study in the recent pharmaceutical outline and its importance is growing day-by-day. The present review covers the various strand related to the analytical method development for impurity profiling of API and pharmaceutical products.