MANUFACTURING METHOD OF HIGH YIELD N-(O-(P-PIVALOYLOXYBENZENESULFONYLAMINO)BENZOYL)GLYCINE, AND LYOPHILIZED FORMULATION OF STABILIZED MONOSODIUM SALT*4 HYDRATE

摘要

PURPOSE: A manufacturing method of lyophilized formulation is provided to enhance solubility and stability for long time.;CONSTITUTION: A manufacturing method of lyophilized formulation of stabilized monosodium salt*4 hydrate comprises the following steps: suspending a compound of chemical formula (I) in an aqueous solution; obtaining a homogeneous solution by controlling the pH of the suspended solution as 7.5-8.5 using sodium ethoxide; and manufacturing lyophilized formulation of tabilized monosodium salt *4 hydrate by lyophilizing the same solution at -50 deg. Celsius and pressure of 10 for 20 hours.;COPYRIGHT KIPO 2013