Final active pharmaceutical ingredient production step

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. 

Basedonarecentreview[14],anaverageof8.1 steps (chemicaltransformation) are usually required for the production of a final active pharmaceutical ingredient (API) from starting materials obtained from the fine chemical industry. Under such... 

In the final step of the synthesis of an active pharmaceutical ingredient (API) up to 15% of diastereomeric impurities were present in the product solution after reaction and workup. Separation of one of the diastereomers ( SSR ) from the desired isomer ( RRR ) proved to be difficult and... 

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