A multidisciplinary approach to identify a degradation product in a pharmaceutical dosage form
| Autor: | Jack Guan, Melissa Lin, Changkang Pan |
|---|---|
| Rok vydání: | 2011 |
| Předmět: |
Spectrometry
Mass Electrospray Ionization Magnetic Resonance Spectroscopy Clinical Biochemistry Pharmaceutical Science Lactose Tandem mass spectrometry Furfural Mass spectrometry High-performance liquid chromatography Dosage form Analytical Chemistry Excipients chemistry.chemical_compound Drug Stability Tandem Mass Spectrometry Drug Discovery Technology Pharmaceutical Furaldehyde Chromatography High Pressure Liquid Spectroscopy Chromatography Chemistry Hydrolysis Microchemistry Nuclear magnetic resonance spectroscopy Ion trap Time-of-flight mass spectrometry Drug Contamination |
| Zdroj: | Journal of Pharmaceutical and Biomedical Analysis. 54:855-859 |
| ISSN: | 0731-7085 |
| DOI: | 10.1016/j.jpba.2010.10.016 |
| Popis: | 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 MS(n) 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. |
| Databáze: | OpenAIRE |
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