Crystallization of Amoxicillin in Presence of Denatured Impurities and their Effect on Crystallization

Abstract

Amoxicillin is prime semi-synthetic antibiotic produced on large scale around the world. Purification and separation are considerable challenges in case of contamination in the production of amoxicillin an API (active pharmaceutical ingredients). A single impurity can turn a huge disaster on a large scale in the manufacturing of amoxicillin. Several researchers have been reported for removal of impurities but still there is a huge gap due to expensive and complex technologies around the world. There are several separation techniques have been reported for purification, but crystallization is significant process for the purification of amoxicillin trihydrate. The crystallization process for the purification of API is pH, time, degree of saturation and temperature controlled. The optimum conditions of pH for crystallization are 4.6 to 5.1 at 4°C, but the problem is that as the concentration of impurities increase the behaviors of crystallization process changes, and in case of amoxicillin it is about to impossible the recovery of amoxicillin at high concentration of impurity. In this research work, the crystallization of amoxicillin is done in presence of different composition of impurities to get the behavior of crystallization process in presence of impurities and to get the optimum set of values of pH, time, degree of saturation and temperature for decontamination of amoxicillin trihydrate. Samples of dried crystallized material are characterized by several analytical techniques such as (XRD, FTIR, HPLC, Turbidity Results).