의약품 원료의 회분식 냉각 결정화 공정에서 접종 효과

Abstract

In the present study a batch cooling crystallization of a pharmaceutical compound designated CPD03 was investigated. To improve the present process, we considered the effect of the seeding temperature and seed amount on CPD03 crystal quality following the programmed cooling curve. To do this, the solubility of CPD02 which is raw material of the present process in IPA/water solvent was measured and the crystallization temperature at various cooling rates was measured. As a result, a metastable zone width and the proper seeding temperature was obtained. And the programmed cooling function with each seeding temperature was calculated. The present experimental result shows that with increasing seeding temperature in metastable zone the mean size of product crystal was increased. This means that a higher seeding temperature brings the less number of nucles because of the lower supersaturation. Also, the effect of seed amount on the product crystal quality was investigated. As a result , the optimum seed amount was obtained.