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The required purge factor is calculated by dividing the maximum PMI level at a defined point¹ in the process, by the acceptable limit in the final API. The acceptable limit, or acceptable daily intake (ADI), is the level of the PMI associated with negligible risk and is typically based on the TTC, the less than lifetime (LTL) limit, or permitted daily exposure (PDE²) as described in ICH M7 R1 [8] (R1 includes the addition of the addendum). The safety‐based limit (acceptable daily exposure [ADE] or PDE) is then converted into a concentration limit based on the clinical dose and duration; typically, these are based on the highest‐anticipated or highest‐approved clinical dose/longest dosing duration.³