A DOSSIER ON IMPURITIES IN PHARMACEUTICALS

ISBN-13: 9786204733869 / Angielski / Miękka / 76 str.

PANKAJ KISAN CHATKI; SANA TABASSUM

Opis

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.

O autorze

KISAN CHATKI, PANKAJPANKAJ KISAN CHATKI:He has 17 years of professional experience in Analytical Research & Development Department. Presently working as Sr. Manager in Slayback Pharma India. Pursued M. Pharmacy, Nagpur University.SANA TABASSUM: Pursued M. Pharmacy from JNTUH. Awarded with RIPE Endowment Gold Medal for having secured 1st Rank in M. Pharmacy from JNTUH.