Establishment of the First Batch of National Drug Reference Standard of Escitalopram Oxalate Impurity A
Objective:To develop the first batch of national drug reference standard of Escitalopram Oxalate Impurity A,which will be used for quality control of escitalopram oxalate tablets and citalopram hydrobromide tablets and so on,in order to ensure the drug safe. Methods:The structure of Escitalopram Oxalate Impurity A was confirmed using LC-MS and NMR. HPLC was employed for purity analysis. The content of Escitalopram Oxalate Impurity A was calculated using the mass balance method,with DSC and qNMR methods used for auxiliary valuation. Results:The structure of the first batch of national drug reference standard of Escitalopram Oxalate Impurity A was characterized and its content was determined to be 97.5％. Conclusion:The first batch of national drug reference standard of Escitalopram Oxalate Impurity A was established,meeting the needs of the related substances inspection in the national standards for these relevant drugs.
Escitalopram Oxalatereference standardstructure confirmationmass balance method19F quantitative nuclear magnetic resonance
万方数据
维普
