Scaling up API Syntheses - Pharmaceutical Technology

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Scaling up API Syntheses
Approaches center on ways to optimize process conditions and operability.


Pharmaceutical Technology
Volume 36, Issue 8, pp. 46-50

Impurity scavengers

Chemicals, intermediates, and reagents as well as byproducts of synthetic processes can have toxic properties and be present as impurities at low levels in an API or final drug formulation. The detection and removal of these impurities are of crucial importance to process chemists, particularly in the case of genotoxic impurities. One of the potentially genotoxic impurities based on structural alerts is acrolein, an α, β-unsaturated aldehyde that is used as a building block in the production of pharmaceuticals (7).

Researchers at MIP Technologies, a subsidiary of Biotage, and the Universität Dortmund in Germany recently reported on an approach for selective removal of acrolein from APIs using iodixanol as a model API. The acrolein scavenging performance of polystyrene- and silica- based aldehyde scavengers in organic media in the presence of the API iodixanol was tested. Several scavengers were tested, and the resins that the showed highest binding efficiency and selectivity were further evaluated. The most effective and selective scavenging was obtained with polystryene–amine, which removed up to 97.8% of acrolein and only 2.0% of iodixanol within 20 min using a batch-mode extraction procedure (7).

Patricia Van Arnum is executive editor of Pharmaceutical Technology, 485 Route One South, Bldg F, First Floor, Iselin, NJ 08830 tel. 732.346.3072,
.

References

1. EPA, "The Presidential Green Chemistry Challenge Awards Program: Summary of 2012 Award Entries and Recipients" (Washington, DC, 2012).

2. P. Van Arnum, Pharm. Technol. 35 (9), 54–58 (2011).

3. EPA, "The Presidential Green Chemistry Challenge Awards Program: Summary of 2010 Award Entries and Recipients" (Washington, DC, 2010).

4. EPA, "The Presidential Green Chemistry Challenge Awards Program: Summary of 2011 Award Entries and Recipients" (Washington, DC, 2011).

5. Y. Tang et al., Science 326 (5952), 589–592 (2009).

6. J. Bennett, Green Synthesis of Aryl Aldimines Using Ethyl Lactate, US Patent Application 20110196174 (Aug. 11, 2011).

7. R. Kecili et al., Org. Proc. Res. Dev. 16 (6), 1225–1229 (2012).


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