INTERNATIONAL JOURNAL OF PHARMACY & LIFE SCIENCES Advance approaches for the impurity profiling of pharmaceutical drugs: A review

In the pharmaceutical world, an impurity is conside red as any other organic material, besides the drug substance, or ingredients, arise out of synthesis or unwanted che micals that remains with API’s. The impurity may be developed either during formulation, or upon aging of both AP I’s and formulated API’s in medicines. The presence of these unwanted chemicals, even in small amount, may influence the efficacy and safety of the pharmaceutical products.Any material that affects the purity of th e material of interest viz. active ingredient or dr ug substance. The impurities are not necessarily always inferior. Fro m the standpoint of its usage, the drug substance i s compromised in terms of purity even if it contains another mate rial with superior pharmacological or toxicological properties. Highly sophisticated instrumentation, such as mass spectra meters attached to a Gas Chromatography or HPLC, are inevitable tools in the identification of minor com ponents (drugs, impurities, degradation products, m etabolites) in various matrices.