Synthesis of Process Related Impurities of Citicoline and Citicoline Sodium

Abstract

Citicoline is the diphosphate ester of cytidine. The said compound is sensitive to chemical atmosphere and exhibits formation of process/degradation impurities. Herewith we report comprehensive synthesis for the pharmacopeia impurities of Citicoline and Citicoline sodium with an objective of providing impurities for better understanding and control in Citicoline. This report provides synthetic methodologies for the impurities, considering ease of handling chemistry and eliminating tedious purification. All the impurities are characterized and confirm the structures.