Abstract

IMPURITY PROFILING: OVERVIEW ON IMPURITY PROFILING AND REPORTING METHODOLOGIES ADOPTED BY UNITED STATES AND EUROPE

Shashank Rawat* and Vijay Kumar

ABSTRACT

Impurities are not acceptable in drug formulation. It is considered as unwanted chemicals or organic material which remains with Active Pharmaceutical Ingredient (API’s). The impurity is produced either during formulation or ageing of both API’s and finished dosage form. The existence of these undesired chemicals may influence the safety and the efficacy of the pharmaceutical finished products. In this review article we have discussed about the methodologies adopted by United States and Europe for Impurity profiling given by their respective regulatory authorities. Impurity profiling, calculation and methodologies used to represent impurities in dossier regulation related documents.

Keywords: Impurity, Residual Solvent, API, SFC.