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ICH Q3D: Metal Impurities: A Critical Evaluation
Historically, control over metal impurities has been achieved via pharmacopoeial heavy metals limit tests, e.g. United States Pharmacopeia (USP) <231>. These tests involve the formation of a...
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ICH M7 Mutagenic impurities: A critical evaluation
Whereas the existing ICH quality documents covering impurities in new drug substances (ICH Q3A(R2)) and drug products (ICH Q3B (R2)) provide a framework for the qualification and control of most...
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