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
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.