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If the predicted purge ratio is < 1000 but ≥ 100, then additional data (e.g. reactivity, solubility, and relevant test data) may be required to support the purge argument and the subsequently defined control strategy. This should be assessed on a case‐by‐case basis and allied to the factors that are most critical to the overall purge of the PMI in question. For example, if the removal of a PMI is predominately due to its solubility, then providing supporting solubility data may be key to underpinning the overall purge factor.