INFLUENCE OF CRYSTALLIZATION TEMPERATURE (10°C AND 28°C) ON PHYSICOCHEMICAL PROPERTIES OF AMOXICILLIN TRIHYDRATE

The crystallization process was one of the crucial processes in amoxicillin trihydrate production. This research used two different temperatures in the crystallization process: low (10°C) and room temperature (28°C). The room temperature process does not require a chiller and an easy-to-maintain temperature, so it was significantly efficient when scaled up to pilot scale or higher. This research investigated the influence of crystallization temperature on the physicochemical properties of amoxicillin trihydrate. The HPLC analysis showed that amoxicillin purity at low temperature (99.83%) and room temperature (96.04%) meet the standard requirement (90.00-105.00%) by Pharmacopeia. Crystallization at room temperature had a smaller yield value and larger particle size, but density, water content, FTIR, and XRD analysis were not significantly different.