A well-behaved crystallisation of a pharmaceutical compound

Theoretical approaches to crystallisation process development were tested on a pharmaceutical development compound and resulted in a well-behaved crystallisation. The crystallisation type was selected from thermal data. Yield and productivity were fixed from the solubility curve. Solution eutectic data were used to set the specification of enantiomeric purity for the input material. Agitation and cooling parameters were established using scale-down laboratory trials. Heat transfer was the rate-limiting step for crystal growth. In-tine technology was beneficial in the laboratory but not necessary on scale-up.