Utilization Of LCMS And NMR To Identify And Confirm A Degradation Product In The Stability Sample Of A Pharmaceutical Dosage Form

摘要

Using the combination of LCMS and NMR, the unknown found in the stability samples has been identified and confirmed as 5-Hydroxymethyl furfural, resulting from the degradation of lactose excipient under stability conditions. The reaction mechanism seems to result from multiple dehydration steps.