RISK ASSESSMENT - GENOTOXIC IMPURITIES IN CELECOXIB [CLASS - COX-2 SELECTIVE INHIBITOR]

Debabrata Sanyal#*, Jitendra Verdia and Narendra Joshi

ABSTRACT

Genotoxic impurities are distinguished class of impurities that can cause genetic mutations and/or chromosomal rearrangements at very low levels. Control of genotoxic impurities is a crucial activity that is required for any pharmaceutical entity. The key element in this is the risk assessment of associated genotoxic concern. Based on the outcome of risk assessment, appropriate strategy for control and monitoring is decided. This article reveals a risk assessment case study carried out on Celecoxib, an active pharmaceutical ingredient, to evaluate the associated genotoxic concern.

Keywords: Genotoxic, Celecoxib.