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Predicting Generation of Potential Mutagenic Impurities within Mirabilis using the Condition Approach

O’Connor D; Gavins G; Burns M; McManus J; Hill N; Rodriguez M;

Performing a mutagenic impurity risk assessment requires evaluating the possible mutagenicity of all structures reasonably expected to be encountered in an active
pharmaceutical ingredient (API) synthesis. All potentially mutagenic impurities (PMIs) must be demonstrated to be suitably controlled by the process. This can be done by analytical testing or through purge assessments, which represent a semi-quantitative means of assessing carryover without the need for significant analytical testing. In the case of Valsartan, the potential formation of NDMA (following a change in the original manufacturing process) was missed and subsequently no assessment of control was performed.
Improvements to Mirabilis aim to facilitate the risk assessment process by utilising a new “condition approach”. The approach allows implementation of “alerts” which will provide the user with a warning when a combination of intermediates and conditions may result in the formation of a PMI. This poster outlines the Mirabilis condition approach and the new alerts function and was presented at OPRD in New Orleans on 20th June 2022.