Analytical control of genotoxic impurities in the pazopanib hydrochloride manufacturing process.

Abstract

Pharmaceutical regulatory agencies are increasingly concerned with trace-level genotoxic impurities in drug substances, requiring manufacturers to deliver innovative approaches for their analysis and control. The need to control most genotoxic impurities in the low ppm level relative to the active pharmaceutical ingredient (API), combined with the often… (More)
DOI: 10.1016/j.jpba.2009.04.002

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