Scaling up API Syntheses - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

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).


ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
What role should the US government play in the current Ebola outbreak?
Finance development of drugs to treat/prevent disease.
Oversee medical treatment of patients in the US.
Provide treatment for patients globally.
All of the above.
No government involvement in patient treatment or drug development.
Finance development of drugs to treat/prevent disease.
23%
Oversee medical treatment of patients in the US.
14%
Provide treatment for patients globally.
7%
All of the above.
47%
No government involvement in patient treatment or drug development.
9%
Jim Miller Outsourcing Outlook Jim MillerOutside Looking In
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerAdvances in Large-Scale Heterocyclic Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler New Era for Generic Drugs
Sean Milmo European Regulatory WatchSean MilmoTackling Drug Shortages
New Congress to Tackle Health Reform, Biomedical Innovation, Tax Policy
Combination Products Challenge Biopharma Manufacturers
Seven Steps to Solving Tabletting and Tooling ProblemsStep 1: Clean
Legislators Urge Added Incentives for Ebola Drug Development
FDA Reorganization to Promote Drug Quality
Source: Pharmaceutical Technology,
Click here