This second article on genotoxic / mutagenic impurities (GTIs) will focus on toxicological aspects and discuss in more detail some of the themes mentioned in the first part of the series [1]. The current [2,3] and evolving guidance [4] is based on a number of key toxicological principles:
This third article in a series on genotoxic/mutagenic impurities (GTIs)
will discuss the challenges facing synthetic and analytical chemists
as they endeavor to identify and ultimately control levels of these
GTIs or PGIs (potentially genotoxic impurities) in drug substance and
drug products. ...