(381ap) Study on the Crystallization Process of 7-Adca Pivaloamide

Abstract: 7-ADCA pivaloamide is an impurity of the cephalexin. In order to control the quality of the drug, there is a clear requirement for the impurity content in the process of drug registration and declaration. The international counterparts research and verify the impurity reference substance in the drug to complete requirements. At present, compared with impurity reference substance, bulk produced 7-ADCA pivaloamide have some quality flaws such as low purity, small size，wide distribution of particle size. In addition, 7-ADCA pivaloamide in the crystallization process is likely to appear into the oil, coalescence and other phenomena. The crystallization process is extremely unstable. In order to improve the quality of 7-ADCA pivaloamide product, the crystallization process of 7-ADCA pivaloamide was systematically studied here.

By examining the effect of the reaction crystallization and the anti-solvent crystallization of the product on crystallinity and yield of the product, it was determined that the anti-solvent crystallization was used as the process to be optimized. Through the comprehensive study of the concentration of the solution, temperature, stirring and other operating parameters on the product performance and process indicators, the anti-solvent crystallization was determined.