Recent Approaches of Impurity Profiling In Pharmaceutical Analysis

There is an ever-increasing interest in impurities present in APIs. Now days, not only purity profile but also impurity profile has become mandatory according to various regulatory authorities like USFDA, CDSCO, MHRA, TGA. In the pharmaceutical world, an impurity is considered as any other inorganic or organic material, or residual solvents other than the drug substances or ingredients. Impurity profiling includes identification, structure elucidation, quantitative determination of impurities, degradation products in bulk drug materials and pharmaceutical formulations.

Identification of impurities is done by variety of Chromatographic and Spectroscopic techniques, either alone or in combination with other techniques. There are different methods for detecting and characterizing impurities with TLC, HPLC, HPTLC, etc. The present review covers various aspects related to the analytical method development for impurity profiling of Active Pharmaceutical ingredient and pharmaceutical products and the possible measures to deal with the interferences caused by them in pharmaceutical analysis.