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Application and Methodology of the Non-destructive 19F Time-domain NMR Technique to Measure the Content in Fluorine-containing Drug Products
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JoVE Journal Chemistry
Application and Methodology of the Non-destructive 19F Time-domain NMR Technique to Measure the Content in Fluorine-containing Drug Products

Application and Methodology of the Non-destructive 19F Time-domain NMR Technique to Measure the Content in Fluorine-containing Drug Products

DOI:
10.3791/55850-v

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09:24 min

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August 22, 2017

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, , , , , ,
1Department of Attribute Sciences,Amgen, Inc., 2Small Molecule Pharmaceutical Sciences,Genentech, Inc., 3NMR Service + Consulting, 4Mestrelab Research

Chapters

  • 00:05Title
  • 00:51Preparation of Samples and NMR Instrument for 19F TD-NMR Measurement
  • 01:56Measurement of the T1 or Longitudinal Relaxation Time for Standard Pure API Samples
  • 03:23Measuring Calibration Samples with Pure API
  • 04:29Measuring Drug Product Samples as Tablets
  • 04:59Generation of Calibration Curves with Pure API Samples and Adding the Data from Drug Product Samples as Tablets in the Calibration Curve
  • 06:59Calculation of the Fluorinated API Drug Weight in the Formulated Drug Product Using the Calibration Curves
  • 07:33Results: Evaluation of the Average Drug Content of Cinacalcet in Tablet Dosage Forms by Low-field Fluorine-19 Time-domain Nuclear Magnetic Resonance
  • 08:29Conclusion

Summary

Automatic Translation

Automatic Translation

A simple and non-destructive technique that measures the average content of drug substances in formulated drug products containing fluorine using low-field fluorine-19 (19F) time-domain (TD) nuclear magnetic resonance (NMR) is presented here. The technique can be applied to the development and manufacturing of drugs in the pharmaceutical industry.

Tags

Keywords: 19F NMRNon-destructive AnalysisDrug ContentPharmaceuticalsFormulationCalibrationT1 Relaxation TimeAPIRINMR Software

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