Importance Of Impurity Profiling In Drug Substances

The description, characterization and quantitation of the identified and unidentified impurities present in new drug substances is known as impurity profile. A general scheme is set for the estimation of the impurity of bulk drug substances by the rational use of chromatographic, spectroscopic and analytical techniques. The various parameters to be fulfilled in an impurity profile of drug substances are discussed. IntroductionImpurity is defined as any substance coexisting with the original drug, such as starting material or intermediates or that is formed, due to any side reactions. Impurity can be of three types: Impurities closely related to the product and coming from the chemical or from the biosynthetic route itself, Impurities formed due to spontaneous decomposition of the drug during the storage or on exposure to extreme conditions, or the precursors which may be present in the final product as impurities.