The increased usage of purge arguments for demonstrating
control
of mutagenic impurities in drug substances, in accordance with ICH
M7, necessitates an increasingly standardized approach to their implementation
across industry. The strength of the approach is highly reliant upon
a conservative implementation of the principles to maintain regulatory
confidence. Different parameters may influence a purge calculation,
such as reactivity, solubility, and volatility. While reactivity data
are commonly available in literature, there are comparatively fewer
resources to draw upon when assigning purge values for solubility
related purifications, despite these processes accounting for high
degrees of purge and there being an abundance of different techniques
which can be utilized. Herein, the authors seek to outline general
principles to be adopted as an industry wide best practice for the
application of solubility-based purge factors.
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