Recent Advances in the Analysis of Organic Impurities of Active Pharmaceutical Ingredients and Formulations: A Review

Paraskevas      D. Tzanavaras

doi:10.2174/138527210793351481

Abstract

Impurity profiling of active pharmaceutical ingredients is a critical quality control parameter during all stages of the development, production and stability testing of pharmaceutical formulations. Literature on this is continuously increasing, it is therefore important to keep track on the latest achievements and applications. This review presents an overview of the most recently published results on the analysis of organic impurities in pharmaceutical samples and active ingredients. Special attention is given to the most widely used techniques, such as liquid chromatography, capillary electrophoresis and mass spectrometry.

Keywords: Impurity profiling, Analytical techniques, Stability-indicating assays, Active pharmaceutical ingredients, betamethasone-E-enolaldehyde, betamethasone-Z-enolaldehyde, Charged Aerosol Detector, CAD, mildronate, hydrophilic interaction chromatography, HILIC, Capillary electrophoresis, CE, cyclodextrin derivatives, Normal Stacking Mode, NSM, Reverse Migrating Micelles Mode, SRMM, APCI, Atmospheric Pressure Chemical Ionization, Atmospheric Pressure Ionization, Background Electrole, Charge Aerosol Detector, Micellar Electrokinetic Chromatography, Pseudostationary Phase, Thermal Surface Ionization