Method for the determination the purity of 5-Azacytidine

摘要

The present invention further provides an analytical method for determining the purity of 5-Azacytidine in a sample, said method comprising : a) providing a sample of 5-Azacytidine, b) dissolving a first part of the sample in dimethyl sulfoxide ("DMSO"), and a second part of the sample in dimethylpropyleneurea ("DMPU"), providing a first and a second sample solution, c) injecting each sample solution onto an HPLC column under the same conditions, providing a first and a second chromatogram, and d) determining the purity of 5-Azacytidine and the amount of each impurity based on both chromatograms.