IMPURITY PROFILING AND DRUG CHARACTERIZATION: BACKDROP AND APPROACH

Impurities are always an ‘essential evil', that will however be present with the drug products with but with the dawn of more safety based limits for controlling the related impure substances (ICH Q3A-D and M7) it can be relied that such controlling authorities will better comprehend the course of action and consent to an appropriate tolerable limits to possibility (commercial and patient needs).Impurity produced either through formulation or in the lead ageing of both API's and formulated products in medicines. These unwanted chemicals, present even in small amount, may influence the efficacy and safety of the pharmaceutical products. Any substance/ unwanted chemical that is present in the active ingredient or drug substance which affects the purity of the material is not always inferior in quality. From the point of view of its applicability, the drug substance is compromised in terms of purity even if it contains another material with superior pharmacological or toxicological properties. Highly sophisticated instrumentation, viz MS attached to a Gas Chromatography or HPLC, LC-MS and other hyphenated and double hyphenated techniques are foreseeable tools in the identification of minor components (drugs, impurities, degradation products, metabolites) in various matrices. Keywords: Analytical Method Validation, Forced degradation studies, ICH Guidelines Impurity profiling, Hyphenated techniques