ISSN: 2639-2534
Authors: Bachhav R*, Khirnar A, Bachhav P, Deore R, Sonawane G and Patil D
Purity profiling is the process of gathering and analyzing information to determine the biological safety of a specific impurity, hence highlighting its importance and range in pharmaceutical research. In the field of pharmaceuticals, impurity has no precise meaning. Identification, structural elucidation, and quantitative determination of impurities and degradation products in bulk medicinal materials and pharmaceutical formulations are all included in impurity profiling. Since unrecognized, possibly poisonous impurities are dangerous to health and should be found and determined by selective procedures in order to increase the safety of drug therapy, impurity profiling has become more significant in contemporary pharmaceutical analysis. Impurities are typically described using words like residual solvents, byproducts, transformation products, degradation products, interaction products, and related products. Impurity identification is carried out using different chromatographic methods in addition to passing the CGMP, QC, QA, and water activity tests, a pharmaceutical ingredient also needs to satisfy the requirements for a new impurity. It is important to separate and characterize impurities in order to collect and evaluate data that determines biological safety, which emphasizes the need for and promise of drug impurity profiling in pharmaceutical research. To separate and measure the pollutants, a range of instrumental analytical techniques have been consistently used. The detection and regulatory evaluation of organic impurities is a very challenging task because to the numerous sources of organic impurities, including microbiological contamination, API breakdown products, and traces of intermediates.
Keywords: Impurity Profiling; Impurities; Identification; Characterization; Chromatography; Spectroscopy
