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This Q&A relates to the need of assigning limits to individual impurities when three or more Class 2 and Class 3 impurities are present.

Question

Answer

Does “Table 2.2: Acceptable Intakes for an Individual Impurity” apply when three or more Class 2 or Class 3 impurities are specified in the DS specification?

Yes. In this scenario, a limit for each “Individual Impurity” should be listed in the DS specification as per limits provided in Table 2.2 (for example >10 years to lifetime not more than (NMT) 1.5 μg/day). Additionally, a limit for “Total Mutagenic Impurities” should be listed in the DS specification as per limits provided in Table 2.7 (for example >10 years to lifetime NMT 5 μg/day). As stated in the guidance, compound‐specific or class‐related acceptable limits (Class 1) and degradation products that form in the DP are excluded from total mutagenic impurity limits.

This Q&A clarifies that in the case where there are three or more Class 2 and Class 3 impurities, the expectation is to assign individual limits for each of the impurities in addition to assigning a limit for “Total Mutagenic Impurities.”