News from Europe's pharmaceutical manufacturing industry coupled with upcoming events, and exclusive articles and interviews from industry experts. WEEKLY
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..
Figure 10 shows the NIR predicted CPM concentrations versus the HPLC results for each tablet in the calibration set. One tablet was left out of the calibration set at each level for
prediction-model validation. Figure 11 shows the NIR predictions of the validation set versus the HPLC results for CPM on each tablet.
Figure 9
Better precision and accuracy can be achieved with a training set designed with smaller increments around the target label
claim. Tablets from on-line press processing can be scanned and sent to the laboratory for HPLC analysis and selected for
calibration samples to cover the range using a few extra pilot-batch samples needed to extend the range to ±15% of label claim.
Conclusion
Figure 10
Near-infrared assay and content uniformity of tablets provides a fast, accurate means of monitoring tablets for production
that is in step with the US Food and Drug Administration's process analytical technology initiative. The data show promising
results that could relieve laboratory workload of high-performance liquid chromatography analysis and bring analysis closer
to "real time" for process monitoring. Ten tablets can be analyzed in <5 min. The software provided with the instrument is
used for data collection and developing prediction models. The software also provides dedicated routine analysis methods for
content-uniformity analysis yielding results in percent label claim and percent relative standard deviation as well as pass–fail
indication.
Figure 11
The average repeatability result for five different tablets measured 10 times of nominal 0.1-mg chlorpheniramine maleate was
0.0039 with a bias of 0.0018. The repeatability result for 5 tablets of 0.5 mg chlorpheniramine maleate was 0.0055 with a
bias of 0.0057. Better precision and accuracy can be achieved with a training set designed with smaller increments around
the target label claim.
Robert Mattes* is an applications scientist at FOSS NIRSystems, Inc., 7703 Montpelier Rd., Laurel, MD 20723 tel. 301.680.7251, fax 301.236.0134,
rmattes@foss-nirsystems.com and Denise Root is a marketing manager at FOSS NIRSystems. Om Anand, Maria Gerald Rajan, Namrata R. Trivedi, and Wen Qu are graduate students, and Yingxu Peng, PhD, and Yichun Sun, PhD, are postdoctorate fellows, Department of Pharmaceutical Sciences, University of Tennessee, Memphis, TN.
Om Anand is a graduate student in the Department of Pharmaceutical Sciences, University of Tennessee, Memphis, TN.
Articles by Om Anand
Maria Gerald Rajan
Maria Gerald Rajan is a gradutate student in the Department of Pharmaceutical Sciences, University of Tennessee, Memphis, TN.
Articles by Maria Gerald Rajan
Namrata R. Trivedi
Namrata R. Trivedi is a gradutate student in the Department of Pharmaceutical Sciences, University of Tennessee, Memphis, TN.
Articles by Namrata R. Trivedi
Wen Qu
Wen Qu is a graduate student in the Department of Pharmaceutical Sciences, University of Tennessee, Memphis, TN.
Articles by Wen Qu
Yingxu Peng
Yingxu Peng, PhD, is a postdoctorate fellow in the Department of Pharmaceutical Sciences, University of Tennessee, Memphis, TN.
Articles by Yingxu Peng
Yichun Sun
Yichun Sun, PhD, is a postdoctorate fellow in the Department of Pharmaceutical Sciences, University of Tennessee, Memphis, TN.
Articles by Yichun Sun
Survey
How does your company apply quality-by-design (QbD) principles to manufacturing processes?
To all processes for both new and legacy products
21%
To all process for new products only
13%
To select process for new products only
26%
To select processes for both new and legacy products
