Recommended

New webinar with Fujifilm: Monocyte activation test (MAT): Insight into examining regulations and markets prospects
New webinar: The path to optimisation in pharmaceutical microbiology
Join our webinar: An alternative medium to support sterility testing using the Growth Direct® Rapid Sterility System
Discover more in our new application note: validating recombinant cascade reagents in 3 simple steps
reference

Elder D. Separation and purification applications for mutagenic impurities. European Pharmaceutical Review. 2017;3:64-67

References Fujiwara M, Nagy ZK, Chew JW, Braatz RD. First-principles and direct design approaches for the control of pharmaceutical crystallization. J. Proc. Control. 2005;15:493-504. ICH M7, 2014. Assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk. Current Step 4 version. 23 June 2014. Teasdale A, Elder DP, Chang S-J, […]

References

  1. Fujiwara M, Nagy ZK, Chew JW, Braatz RD. First-principles and direct design approaches for the control of pharmaceutical crystallization. J. Proc. Control. 2005;15:493-504.
  2. ICH M7, 2014. Assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk. Current Step 4 version. 23 June 2014.
  3. Teasdale A, Elder DP, Chang S-J, Wang S, Thompson R, Benz N, Sanchez Flores IH. Risk Assessment of Genotoxic Impurities in New Chemical Entities: Strategies to Demonstrate Control. Org. Proc. Res. Dev. 2013;17:221-230.
  4. Teasdale A, Elder DP, Fenner S. Strategies for the evaluation of genotoxic risk. In: Genotoxic impurities: Strategies for Identification and Control, Ed. Teasdale A. John Wiley and Sons, Inc. 2010. pp.221-248.
  5. Maddula SR, Kharkar M, Manudhane K, Kale S, Bhori A, Lali A, Dubey PK, Sarma KRJ, Bhattacharya A, Bandichhor R. Preparative Chromatography Technique in the Removal of Isostructural Genotoxic Impurity in Rizatriptan: Use of Physicochemical Descriptors of Solute and Adsorbent. Org. Proc. Res. Dev. 2009;13(4):683-689.
  6. Sutherland I, Ignatova S, Hewitson P, Janaway L, Wood P, Edwards N, Harris G, Guzlek H, Keay D, Freebairn K, Johns D, Douillet N, Thickitt C, Vilminot E, Matthews B. Scalable technology for the extraction of pharmaceutics (STEP): The transition from academic knowhow to industrial reality. J. Chromatographr. A. 2011;1218:6114-6121.
  7. Sutherland I, Thickitt C, Douillet N, Freebairn K, Johns D, Mountain C, Wood P, Edwards N, Rooke D, Harris G, Keay D, Matthews B, Brown R, Garrard I, Hewitson P, Ignatova S. Scalable technology for the extraction of pharmaceutics (STEP): Outcomes from a 3 year collaborative industry/academia research programme. J. Chromatographr. A. 2013;1282:84-94.
  8. Biba M, Liu J. 2016. A perspective on the application of preparative supercritical fluid chromatography using achiral stationary phases in pharmaceutical drug discovery and development. Amer. Pharm. Review. April 30.2016; (1-7). http://www.americanpharmaceuticalreview.com/Featured-Articles/185891-A-Perspective-on-the-Application-of-Preparative-Supercritical-Fluid-Chromatography-Using-Achiral-Stationary-Phases-in-Pharmaceutical-Drug-Discovery-and-Development/. Accessed on 16 May 2017.
  9. Székely G, Bandarra J, Heggie W, Sellergreen B, Ferreira FC. 2011. Organic solvent nanofiltration. A platform for removal of genotoxins from active pharmaceutical ingredients. J. Memb. Sci. 2001:381:21-33.
  10. Székely G, Bandarra J, Heggie W, Sellergreen B, Ferreira FC. 2012. A hybrid approach to reach stringent low genotoxicity impurity contents in active pharmaceutical ingredients: Combining molecularly imprinted polymers and organic solvent nanofiltration for removal of 1,3-diisopropyurea. Sep. Purif. Technol. 2012;86:79-87.
  11. Marchetti P, Jimenez Solomon MF, Szekely G, Livingston AG. Molecular Separation with Organic Solvent Nanofiltration: A Critical Review. Chem. Rev. 2014;114: 10735-10806.
  12. Bandarra J, Heggie W, Szekely, G. 2012. Organic solvent nanofiltration for the removal of genotoxic impurities from APIs. PT105601(A).
  13. Kim JF, Szekely G, Valtcheva IB, Livingston AG. Increasing the sustainability of membrane processes through cascade approach and solvent recovery—pharmaceutical purification case study. Green Chem. 2014;16:133.
  14. Peeva L, da Silva Burgal J, Valtcheva I, Livingston AG. Continuous purification of active pharmaceutical ingredients using multistage organic solvent nanofiltration membrane cascade. Chem. Eng. Sci. 2014;116:183.
  15. Vanneste J, Ormerod D, Theys G, Van Gool D, Van Camp B, Darvishmanesh S, Van der Bruggen B. Towards high resolution membrane-based pharmaceutical separations. J. Chem. Technol. Biotechnol. 2013;88:98-108.
  16. Siew W, Livingston AG, Ates C, Merschaert A. Molecular separation with an organic solvent nanofiltration cascade – augmenting membrane selectivity with process engineering. Chem. Eng. Sci. 2013;90:299-310.
  17. Siew WE, Livingston AG, Ates C, Merschaert A. Continuous solute fractionation with membrane cascades – A high productivity alternative to diafiltration. Sep. Purif. Technol. 2013;102:1-14.
  18. Pink CJ, Wong H, Ferreira FC, Livingston AG. Organic Solvent Nanofiltration and Adsorbents; A Hybrid Approach to Achieve Ultra Low Palladium Contamination of Post Coupling Reaction Products. Org. Process Res. Dev. 2008;12:589-595.
  19. Whitcombe MJ, Kirsch N, Nicholls LA. Molecular imprinting science and technology: A survey of the literature for the years 2004-2011. J. Molec. Recogn. 2014;27:297-401.
  20. Székely G, Fritz E, Bandarra J, Heggie W, Sellergreen B. Removal of potentially genotoxic acetamide and arylsulfonate impurities from crude drugs by molecular imprinting. J. Chromatographr. A. 2012;1240:52-58.
  21. Kecili R, Billing J, Leeman M, Nivhede D, Sellergren B, Rees A, Yilmaz E. Selective scavenging of the genotoxic impurity methyl p-toluenesulfonate from pharmaceutical formulations. Sep. Purif. Technol. 2013;103:173.
  22. Kecili R, Nivhede D, Billing J, Leeman M, Sellergren B. Yilmaz E. Removal of Acrolein from Active Pharmaceutical Ingredients Using Aldehyde Scavengers. Org. Process Res. Dev. 2012;16:1225.
  23. Székely G, Bandarra J, Heggie W, Ferreira FC, Sellergreen B. Design, preparation and characterization of novel molecularly imprinted polymers for removal of potentially genotoxic 1,3-diisopropyurea. Sep. Purif. Technol. 2012;86:190-198.
  24. Kecili R, Billing J, Nivhede D, Sellergren B, Rees A, Yilmaz E. J. Fast identification of selective resins for removal of genotoxic aminopyridine impurities via screening of molecularly imprinted polymer libraries. J. Chromatogr. A. 2014;1339:65.
  25. Esteves T, Viveiros R, Bandarra J, Heggie W, Casimiro T, Ferreira FC. Molecular imprinted polymer strategies for removal of a genotoxic impurity, 4-dimethylaminopyridine, from an active pharmaceutical ingredient post-reaction stream. Sep. Purif. Technol. 2016;163:206-214.
  26. Kupai J, Razali M, Buyuktiryaki S, Kecilic R, Szekely G. Long-term stability and reusability of molecularly imprinted polymers. Polym. Chem. 2017;8:666-673.
  27. Viveiros R, Lopes MI, Heggie W, Casimiro T. Green approach on the development of lock-and-key polymers for API purification. Chem. Eng. J. 2017;308:229-239.
  28. Lee C, Helmy R, Strulson C, Plewa J, Kolodziej E, Antonucci V, Mao B, Welch CJ, Ge Z, Al-Sayah MA. Removal of Electrophilic Potential Genotoxic Impurities Using Nucleophilic Reactive Resins. Org. Proc. Res. Dev. 2010;14(4):1021-1026.