| Article ID | Journal | Published Year | Pages | File Type |
|---|---|---|---|---|
| 10553561 | Journal of Pharmaceutical and Biomedical Analysis | 2011 | 5 Pages |
Abstract
An unknown degradation product found in non-MS compatible HPLC analysis was studied using a multidisciplinary approach. The unknown was separated and isolated from other components in the drug product by HPLC followed by ion trap MS to obtain MSn fragmentation patterns. Its chemical formula was determined using a high resolution time-of-flight mass spectrometer (TOF MS). Nuclear Magnetic Resonance (NMR) was used to elucidate the molecular structure. The impurity was identified as 5-hydroxymethyl furfural, which was a degradation product of lactose, one of the excipients used in the formulation of this dosage form.
Related Topics
Physical Sciences and Engineering
Chemistry
Analytical Chemistry
Authors
Changkang Pan, Jack Guan, Melissa Lin,