Near-Infrared Assay and Content Uniformity of Tablets - Pharmaceutical Technology

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Near-Infrared Assay and Content Uniformity of Tablets
Near-infrared (NIR) assay and content uniformity of tablets provide fast, accurate means of monitoring tablet production that are in step with FDA's process analytical technology initiative.The authors discuss the process for testing a newly released NIR tablet analyzer to determine instrument precision and accuracy using chlorpheniramine maleate tablets.The data show promising results that could relieve laboratory workload of high-performance liquid chromatography analysis and bring analysis closer to..


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2. US Food and Drug Administration, Guidance for Industry: PAT—A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance, (FDA,Rockville, MD, Sept. 2004).

3. P.J. Larkin, E. Fruhling, and C. Longfellow, "Comparison of Fourier Transform (FT) and Grating Based NIR Spectrometers for Content Uniformity of Pharmaceutical Solid Dosage Forms," Am. Pharm. Review. 9 (6), 102–109 (2006).

4. Q. Ji et al., "Rapid Content Uniformity Determination of Low-Dose TCH 346 Tablets by NIR," Am. Pharm. Review 9 (5), 20–26 (2006).

5. R. Kramer, Chemometric Techniques for Quantitative Analysis, (Marcel Dekker, Inc., New York, NY, 1998).

6. K.R. Beebe, R.J. Pell, and M.B. Seasholtz, Chemometrics: A Practical Guide, (John Wiley & Sons, Hoboken, NJ, 1998).


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