SOURCES OF IMPURITIES: A REVIEW

Abstract

Impurity is defined as an entity of drug substance or drug product that is not chemical entity defined as drug substance, an excipient, or other additives to drug products. In Webster’s dictionary, impurity is “something that is impure or makes something else impure. In the pharmaceutical world, an impurity is generally considered as any other organic material besides the drug substance that arises out of the synthesis most of the time; inorganic contaminants are not considered as impurities unless they are toxic, such as heavy metals or arsenic. There are numerous sources of impurities and many different common terms are used for impurities such as Intermediates, Penultimate intermediates, Byproducts, Transformation products, Interaction products, related products and Degradation products. In this review, a description of different types of impurities in relation to ICH guidelines including specific examples, are presented