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Volume 60, Issue 4
  • ISSN: 2056-5135
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Abstract

In this article, we will look at palladium impurity removal from active pharmaceutical ingredient (API) process streams using metal scavengers and the drivers for the implementation of such processes. The article will review some of the available scavengers and detail how Johnson Matthey approaches the trial work and the methods used for screening, optimisation and scale-up of the scavenger process. It will outline the steps taken to ensure smooth transfer of the metal impurity removal process from lab to plant. This will include Johnson Matthey data from batch isotherm, kinetic and fixed bed trials and the application of mathematical models for performance characterisation and scale-up, which all feed into the final system design. Performance data for a number of the Johnson Matthey range of scavengers will be referenced both in batch and cartridge systems and the benefits of using the scavengers in a cartridge system will be presented.

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2016-01-01
2024-11-05
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References

  1. “ICH Harmonised Guideline, Guideline for Elemental Impurities, Q3D”, Current Step 4 Version, International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, 16th December, 2014: http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q3D/Q3D_Step_4.pdf (Accessed on 26th August 2016) [Google Scholar]
  2. C. C. C. Johansson Seechurn, M. O. Kitching, T. J. Colacot, V. Snieckus, Angew. Chem. Int. Ed., 2012, 51, (21), 5062 LINK http://dx.doi.org/10.1002/anie.201107017 [Google Scholar]
  3. J. Magano, J. R. Dunetz, ‘Large-Scale Applications of Transition Metal Removal Techniques in the Manufacture of Pharmaceuticals’, in “Transition Metal-Catalyzed Couplings in Process Chemistry: Case Studies from the Pharmaceutical Industry”, eds. J. Magano, Wiley-VCH Verlag, Weinheim, Germany, 2013, p. 313 LINK http://www.wiley.com/WileyCDA/WileyTitle/productCd-3527332790.html [Google Scholar]
  4. E. J. Flahive, B. L. Ewanicki, N. W. Sach, S. A. O’Neill-Slawecki, N. S. Stankovic, S. Yu, S. M. Guinness, J. Dunn, Org. Process Res. Dev., 2008, 12, (4), 637 LINK http://dx.doi.org/10.1021/op600280g [Google Scholar]
  5. S. Phillips, P. Kauppinen, Platinum Metals Rev., 2010, 54, (1), 69 LINK http://www.technology.matthey.com/article/54/1/69-70/ [Google Scholar]
  6. G. Reginato, P. Sadler, R. D. Wilkes, Org. Process Res. Dev., 2011, 15, (6), 1396 LINK http://dx.doi.org/10.1021/op200127y [Google Scholar]
  7. J. Frankham, P. Kauppinen, Platinum Metals Rev., 2010, 54, (3), 200 LINK http://www.technology.matthey.com/article/54/3/200-202/ [Google Scholar]
  8. C. J. Welch, J. Albaneze-Walker, W. R. Leonard, M. Biba, J. DaSilva, D. Henderson, B. Laing, D. J. Mathre, S. Spencer, X. Bu, T. Wang, Org. Process Res. Dev., 2005, 9, (2), 198 LINK http://dx.doi.org/10.1021/op049764f [Google Scholar]
  9. M. J. Girgis, L. E. Kuczynski, S. M. Berberena, C. A. Boyd, P. L. Kubinski, M. L. Scherholz, D. E. Drinkwater, X. Shen, S. Babiak, B. G. Lefebvre, Org. Process Res. Dev., 2008, 12, (6), 1209 LINK http://dx.doi.org/10.1021/op800161v [Google Scholar]
  10. C. E. Garrett, K. Prasad, Adv. Synth. Catal., 2004, 346, (8), 889 LINK http://dx.doi.org/10.1002/adsc.200404071 [Google Scholar]
  11. J.-P. Huang, X.-X. Chen, S.-X. Gu, L. Zhao, W.-X. Chen, F.-E. Chen, Org. Process Res. Dev., 2010, 14, (4), 939 LINK http://dx.doi.org/10.1021/op100094p [Google Scholar]
  12. G. Lecornet, ‘Analysis of Elemental Impurities in Drug Products using the Thermo Scientific iCAP 7600 ICP-OES Duo’, Application Note 43149, Thermo Fisher Scientific Inc, Massachusetts, USA, 2016 [Google Scholar]
  13. C. E. Borba, G. H. F. Santos, E. A. Silva, Chem. Eng. J., 2012, 189–190, 49 LINK http://dx.doi.org/10.1016/j.cej.2012.02.017 [Google Scholar]
  14. R. B. Garcia-Reyes, J. R. Rangel-Mendez, Bioresource Technol., 2010, 101, (21), 8099 LINK http://dx.doi.org/10.1016/j.biortech.2010.06.020 [Google Scholar]
  15. J. B. Butt, “Reaction Kinetics and Reactor Design”, Second Edition, Marcel Dekker Inc, New York, USA, 2000, pp. 332–333 [Google Scholar]
  16. V. J. Inglezakis, S. G. Poulopoulos, ‘Heterogeneous Processes and Reactor Analysis’, in “Adsorption, Ion Exchange and Catalysis”, First Edition, Elsevier, Amsterdam, The Netherlands, 2006, pp. 148–160 [Google Scholar]
  17. V. J. Inglezakis, S. G. Poulopoulos, ‘Reactors Scale-up’, in “Adsorption, Ion Exchange and Catalysis”, First Edition, Elsevier, Amsterdam, The Netherlands, 2006, pp. 531–539 [Google Scholar]
/content/journals/10.1595/205651316X693247
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Palladium Impurity Removal from Active Pharmaceutical Ingredient Process Streams
Johnson Matthey Technology Review 60, 277 (2016); https://doi.org/10.1595/205651316X693247
/content/journals/10.1595/205651316X693247
/content/journals/10.1595/205651316X693247
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  • Article Type: Research Article

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