Lhasa Limited collaborates with industry and regulators to define solubility purge best practice
Key to the regulatory acceptance of purge arguments is the conservatism within the purge factor scoring system, which for reactivity purge has been demonstrated across a number of publications and is consistently implemented across the pharmaceutical industry through the development of a collective understanding of and how they should be applied.
Likewise, when volatility purge scoring is relatively simple to understand and apply, particularly using the scoring thresholds originally proposed by Teasdale et al.
However, through our interactions with Mirabilis users, regulators, and other members of the purge community, it has become increasingly apparent that the same cannot be said of solubility purge scoring. Lhasa have therefore identified the huge value to the community of developing an accepted best practice, incorporating both the application of solubility purge scoring and, where appropriate, provision of a clear justification of the purge factor assigned.
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