A DOSSIER ON IMPURITIES IN PHARMACEUTICALS. EMERGENCE, STRATIFICATION, RECKONING ON THRESHOLDS AND IT’S CONTROL

      Аннотация: Presence of impurities in pharmaceutical drug products is a continuous matter of concern for drug and its related products safety. This article assists in recognition of type and source of impurities. Emergence of various genotoxic and non-genotoxic impurities is delineated with diverse examples. Structural explanations are displayed for thresholds estimation, acceptable intake calculations, risk characterization of impurities and setting of limits based on maximum daily dose, tumor incidence with exemplars. Depicted and explained thresholds for drug products based on maximum daily dose assists to confirm whether a product conform purity criteria. Risk characterizations, acceptable intake calculations, setting limits based on different approaches are encompassed. Strategies on how to control impurities are explained with flow charts. This article presently and in future will assist and guide to researchers or scientists or manufacturers or students to identify and control impurities in pharmaceuticals, ultimately drug’s safety and efficacy will be enhanced. Especially the flow charts provided will be obliging and succour to understand this censorious topic.

Ключевые слова: impurities, genotoxic impurities, mutagenic, Carcinogenic, ICH, Cohort of concern, thresholds, Acceptable daily intake, Risk characterization, Nitrosamine, Control Strategy, and Risk Assessment.