Application of (19) F time-domain NMR to measure content in fluorine-containing drug products
Copyright © 2015 John Wiley & Sons, Ltd.
| Veröffentlicht in: | Magnetic resonance in chemistry : MRC. - 1985. - 54(2016), 6 vom: 15. Juni, Seite 531-8 |
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| Weitere Verfasser: | , , , , , |
| Format: | Online-Aufsatz |
| Sprache: | English |
| Veröffentlicht: |
2016
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| Zugriff auf das übergeordnete Werk: | Magnetic resonance in chemistry : MRC |
| Schlagworte: | Journal Article 19 F API NMR PAT drug average content drug product drug substance low field NMR time-domain NMR mehr... |
| Zusammenfassung: | Copyright © 2015 John Wiley & Sons, Ltd. It is necessary to show that the active content in the dosage form of drugs is within a certain narrow range of the label claim. In case of fluorinated drugs, the active content can be measured by high field solid state NMR because the excipients lack fluorine. To make NMR reachable to any laboratory, simple to use, and at a low cost, measurement of (19) F nucleus using a 23 MHz (for (1) H) low field benchtop time-domain (TD) NMR was investigated. Three fluorinated drug products, cinacalcet, lansoprazole, and ciprofloxacin, were chosen for this study. The doses for these drug products range from 15 to 500 mg. The average drug content measured using (19) F TD-NMR compares well with the reported label claims for the three drugs tested. (19) F TD-NMR is a simple and non-destructive technique to measure drug content in tablets. In addition, the accessibility and simplicity of the technique makes it an excellent process analytical technology tool for development and manufacturing in the pharmaceutical industry. Copyright © 2015 John Wiley & Sons, Ltd |
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| Beschreibung: | Date Completed 05.02.2018 Date Revised 02.12.2018 published: Print-Electronic Citation Status MEDLINE |
| ISSN: | 1097-458X |
| DOI: | 10.1002/mrc.4223 |