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.
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