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THE PHARMA REVIEW (SEP – OCT 2018)

Sources, Separation and Identification of Impurities in Pharmaceuticals

Dr. Mehul M. Patel & Harshal J Shah

Introduction:

Abstract: In pharmaceutical field, impurity is considered as any other organic material, besides the drug substance, or ingredients, arise out of synthesis or unwanted chemicals that remains with API’s. Impurity profiling includes identification, structure elucidation and quantitative determination of impurities and degradation products in bulk drug materials and pharmaceutical formulations. There are various forms of impurities incorporated in the pharmaceuticals. These impurities are classified into three main categories such as organic, inorganic and residual solvents. The control of impurities in formulated products and active pharmaceutical ingredients are regulated by various regulatory authorities like US-FDA, ICH, MHRA, TGA etc. Qualification of impurities is most essential for establishing the biological safety of an individual impurity. Various methods are used to isolate and characterize impurities in pharmaceuticals, such as, capillary electrophoresis, electron paramagnetic resonance, gas–liquid chromatography, gravimetric analysis, high performance liquid chromatography, solid-phase extraction methods, liquid–liquid extraction method, ultraviolet spectrometry, infrared spectroscopy, supercritical fluid extraction column chromatography, mass spectrometry, Nuclear Magnetic Resonance (NMR) spectroscopy, and RAMAN spectroscopy. Among all hyphenated techniques, the most exploited techniques for impurity profiling of drugs are Liquid Chromatography (LC)-Mass Spectroscopy (MS), LC-NMR, LC-NMR-MS, GC-MS, and LC-MS. This reveals the need and scope of impurity profiling of drugs in pharmaceutical research.
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