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Active pharmaceutical ingredient change control

Characterization starts once the synthetic route has been selected, although there will be opportunities to modify the route if the changes do not impact the final solid state or impurity profile of the final active pharmaceutical ingredient. The primary objective is to understand, through experimentation, the chemical and physical chemical processes involved in the transformation of raw materials to intermediates and products. The primary outcome is a process definition that includes the order of manufacturing steps, process parameter control methodology, process parameter limits, raw material specification, and diagnostic metrics. [Pg.53]

The purity requirements demanded in the production of fine chemicals for the manufacture of active pharmaceutical ingredients (APIs) have led to a renewed and widespread interest in preparative chromatography. The theoretical understanding of the main factors controlling the process and, therefore the possibility to predict its outcome, has promoted a change in the industrial mentality from the previous reticence. [Pg.1619]


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See also in sourсe #XX -- [ Pg.3936 ]




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