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3.2.6.7 ICH M7 Control Option 1, 2, or 3

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Critically, if the experimentally measured purge factor is insufficient to support an ICH M7 Option 4 control strategy, then the applicant should assess the relative merits of the other ICH M7 control strategies, i.e. Options 1–3 (see Figure 3.2).

Mutagenic Impurities

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