Abstract

REVIEW ON IMPURITY PROFILING

Dhavale Om Manikrao* and Katkar Chaitanya Pradip

Abstract

Impurities are is the undesirable chemicals or organic substances which remains with active pharmaceutical Ingredient (API’s). The impurities is not acceptable for drug administration. The existence of these undesirable chemicals or substances may influence the safety and the efficacy of the pharmaceutical finished products. Highly sophisticated instrumentation such as mass spectra meters attached to a gas chromatography or HPLC are inevitable In identification of minor components (drug, impurities, degradation products, metabolites) in various matrices.

Keywords: Impurity profiling, API, Gas chromatography, HPLC.