Quality Control and Quality Assurance

Abstract

Abstract: This brief review presents the international approaches to assessment of the content of geotaxis impurities (residual solvents and various inorganic and organic impurities) in pharmaceuticals. Nowadays, it has become necessary to provide not only purity profile but also impurity profile of a particular pharmaceutical product because of national and international regulations. The supply of essential medicines of good quality has been identified as one ofthe pre-requisites for the delivery of health care system of any country as poor quality medicines can harm or even kill consumers. The presence of unwanted chemicals in a particular medicine, even in extremely small quantities, may influence its efficiency and safety. Unlike in other industries, a medicine is a dynamic product whose color, consistency, weight, and even chemical identity can change between manufacture and ultimate consumption. Impurities in pharmaceutical products are of great concern not only due to the inherent toxicity of certain contaminants, but also due to the adverse effect that contaminants may have on drug stability and shelf-life. In pharmaceutical and drug products, impurities are the unwanted chemicals (organic, inorganic and residualsolvents) that remain with the active pharmaceutical ingredients (APIs), or develop/added during formulation, or upon aging.