Abstract

IMPURITY PROFILING: AN EMERGING APPROACH FOR PHARMACEUTICALS

Rishi Ram Parajuli*, Priyanka Pokhrel, Mukem Bhattarai and Dr. Bhupendra Shrestha

ABSTRACT

A pharmaceutical impurity is any unwanted chemical or material that remains with API which may have arose out of synthesis or may be developed during formulation process or upon ageing of API and its formulation. The efficacy and safety of pharmaceutical products may be influence by even small amounts of unwanted, unidentified and potentially toxic impurities. Impurity profiling is an emerging approach, the aim of which is detection, identification, structure elucidation and quantitative determination of organic and inorganic impurities and residual solvents in pharmaceutical formulations. Various regulatory authorities like ICH, USFDA, UK-MHRA, Indian CDSCO are emphasizing on the impurity profiling and have formulated the guideline concerning control and limit of impurity. According to ICH guidelines, an impurity present in an excess of 0.1% should be identified and quantified. Identification of impurity is done by reference standard method, spectroscopic method, separation method, isolation method and characterization method using chromatographic and spectroscopic technique. Impurity profiling has numerous applications in the areas of drug designing, quality monitoring, stability and safety of pharmaceutical compounds. Despite of these benefits, there are certain limitations such as requirement of highly sophisticated equipments for identification of minor components, need for repetition of process with change or modification of instruments in case if impurities are not identified and the high cost of equipment.

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