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Protocols for Characterization of Degradation Products with Special Emphasis on Mutagenic Degradation Impurities

Steven Hostyn, Peter Persich,Shalu Jhajra, Koen Vanhoutte

Methods in Pharmacology and Toxicology(2018)

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关键词
Degradation products,Mutagenic degradation impurities,ICH M7,Threshold of toxicological concern,Forced degradation studies,Excipient compatibility,Stability,Characterization protocols
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