Organic impurities in drug substance origin

1 Organic impurities in drug substance origin, control, and measurement 

Linda Ng, George Lunn, and Patrick Faustino 1.1 Introduction 

Impurities generally fall into three main categories process impurities, degradation impurities, and contaminant impurities. Additionally, enantiomers and polymorphs may be considered impurities under some circumstances. 

Impurities that cause the greatest concern are those that are toxic, defined by the US Pharmacopeia (USP) as impurities that have significant undesirable biological activity [ 1 ], and host cell contaminants in biopharmaceuticals that have potential risks of allergic reaction or other immunopathological effects [2]. 

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