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Tablets & Capsules March 2017 31 accuracy of the results and no significant difference in reproducibility was detected (Table 10). To further test the robustness of the tablets-in-a-cup method of analysis, sets of round tablets previously analyzed were prepared with a purposely induced orientation, as shown in Figure 3. No significant differences were observed between the randomly oriented tablet sets and tablet sets that were oriented on edge (Table 11). Figure 3 Induced orientation of tablets a. On-edge orientation b. Flat orientation Conclusions The results reported here demonstrate that the WD- XRF technique has huge potential for analyzing finished pharmaceutical dosage forms according to ICH Q3D and USP <233>. In contrast, most labs that use ICP tech- niques focus their control strategy on raw materials and processes as a means of assessing risk and they avoid rou- tine testing of final dosage forms. Implementing WD- XRF—an easy-to-operate, nondestructive, and direct analysis technique—enables lab personnel to conduct final testing that ensures all products meet safety require- ments. Furthermore, because sample preparation is easy—simply adding tablets to a cup—WD-XRF can be applied in a manufacturing environment with minimal setup. T&C References 1. ICH-Q3D Guideline for Elemental Impurities: Step 4 version dated 16 December 2014. 2. Q3D Elemental Impurities: Guidance for Industry. US FDA, September 2015. 3. General Chapter <232> Elemental Impurities– Limits: 2nd Supplement to USP 39-NF 34. 4. General Chapter <233> Elemental Impurities– Procedures: 2nd Supplement to USP 38-NF 33. 5. Muller, A., Oliveira, J., Mello, P., Muller, E., and Flores, E. Study and determination of elemental impuri- ties by ICP-MS in active pharmaceutical ingredients using single reaction chamber digestion in compliance with USP requirements. Talanta 136: 161-169, 2015. 6. Balaram V. Recent advances in the determination of elemental impurities in pharmaceuticals–Status, chal- lenges and moving frontiers. TrAC Trends in Analytical Chemistry 80: 83-95, 2016. 7. Lewen, N. Preparation of pharmaceutical sample for elemental impurities analysis: Some potential approaches. Spectroscopy 31(4): 36-43, 2016. Glenn Williams, PhD, is manager of XRF analytical services and Thanh Nguyen, PhD, is a senior applications scientist and the corresponding author at Rigaku Americas, 9009 New Trails Drive, The Woodlands, TX 77381. Tel. 281 362 2300. Web- site: www.rigaku.com. Nicole McNulty, an undergraduate stu- dent at the University of Texas-Austin, was an intern at Rigaku.