RECENT APPROCHES OF “IMPURITY PROFILING” IN PHARMACEUTICAL ANALYSIS: A REVIEWAbstract
Impurity is something that is impure or makes something else impure. An impure substance may be defined as follows: a substance of interest mixed or impregnated with an extraneous or usually inferior substance, from the standpoint of its usage, the drug substance is compromised in terms of purity even if it contains another material with superior pharmacological or toxicological properties. The impurity may be developed either during formulation, or upon aging of both API’s and formulated API’s in medicines. The presence of these unwanted chemicals, even in small amount, may influence the efficacy and safety of the pharmaceutical products. The impurities are not necessarily always inferior. Highly sophisticated instrumentation, such as mass spectra meters attached to a Gas Chromatography or HPLC, are inevitable tools in the identification of minor components (drugs, impurities, degradation products, metabolites) in various matrices. Present article reveals different impurities found in the API’s, methods for identifying them and the possible measures to deal with the interferences caused by them in pharmaceutical analysis.
Shreya R. Shah*, Mayur A. Patel, Miral V. Naik, P.K. Pradhan, and U.M. Upadhyay
Department of Quality Assurance, Sigma Institute of Pharmacy, At., Post Bakrol, Ta: Waghodia, Dist: Vadodara-390019, Gujarat, India
04 June, 2012
10 July, 2012
10 September, 2012
01 October, 2012