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Potential impurities in drug substances: Compound-specific toxicology limits for 20 synthetic reagents and by-products, and a class-specific toxicology limit for alkyl bromides

Regulatory Toxicology and Pharmacology(2018)

Cited 34|Views64
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Key words
Drug substance,Impurities,Threshold of toxicological concern (TTC),Acceptable intake (AI),Permissible daily exposure (PDE),Compound-specific limit,Class-specific limit,Monofunctional alkyl bromides
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