Impurities in pharmaceutical products: How, Why, Characterize and Acceptance criteria
ABSTRACT: The purpose of this article is to provide a practical framework that is applicable to the identification, categorization and control of impurities. This guidance emphasizes considerations of both safety and quality risk management in establishing levels of impurities that are expected to pose negligible risk. It outlines recommendations for assessment and control of impurities that reside or are reasonably expected to reside in final drug substance or product, taking into consideration the intended conditions of human use. This article will describe How, Why, Characterization and control for determining the impurities based on their properties. Keywords: impurities , acceptance criteria process-related impurities (PRIs) , degradation-related impurities (DRIs), Classification, Permitted Daily Exposure (PDE), residual solvents. INTRODUCTION: There are number of possible reasons for impurities in pharmaceutical products which are involved either related to proc...