AZITHROMYCIN L-MALATE MONOHYDRATE AND PHARMACEUTICAL COMPOSITION COMPRISING THE SAME

摘要

An azithromycin L-malate monohydrate is provided to show good solubility in water and excellent heat-stability without moisture-absorbing property. And a method for preparing thereof and a pharmaceutical composition comprising the same are provided. The azithromycin L-malate monohydrate is represented by the formula(1), wherein an L-malic acid is L-(-)-malic acid where an asymmetric carbon marked as * has an S-configuration, and prepared by reacting azithromycin represented by the formula(2) with a malic acid represented by the formula(3) or recrystallizing azithromycin L-malate anhydride.