Development and validation of a method for testing content uniformity on pharmaceutical potent oral dosage forms by near-infrared spectroscopy: (Dissertation)
Author: Carlos Arturo Peroza Meza Manufacturer: ProQuest Information and Learning Keywords: Pharmaceutical testing ISBN: B000GKHU1G
Book description Abstract A transmission Near Infrared (NIR) spectroscopic method was developed for the nondestructive determination of drug content in tablets with less than 1% (m/m) drug content along with a sample size study to determine the real sample volume of the material being analyzed. Tablets used had nominal drug concentrations of about 0.5 %, 0.7%, and 1.0 (m/m) and ranging in drug content from 0.71 to 2.51 mg per tablet. Transmission NIR spectra were obtained for 110 tablets that constituted the training set for the calibration model developed with partial least squares (PLS) regression. The reference method for the calibration model was a validated UV spectrophotometric method. Several data
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