Isolation of Pharmaceutical Impurities and Degradants Using Supercritical Fluid Chromatography - Pharmaceutical Technology

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Isolation of Pharmaceutical Impurities and Degradants Using Supercritical Fluid Chromatography
The authors demonstrate that using supercritical fluid chromatography offers distinct advantages in speed and in clean isolation of the desired peaks.


Pharmaceutical Technology
Volume 37, Issue 3, pp. 60-67

Conclusions

SFC is, in many ways, an ideal tool for facilitating trace component capture and analysis. Scalable separations are developed rapidly, large amounts of feed may be rapidly processed, dual strategies may be used exclusively or combined, and milligram quantities of highly pure isolates can be accumulated for structural or biological assays. In addition, the solvent environment is much more benign than conventional chromatography approaches.

SFC can be superior to conventional chromatography approaches in many cases, and should be considered by laboratories. Given the complex nature and long timelines of these projects, and the scale of chromatography that must be undertaken to access trace components, it is worth the effort to identify the best approach to such challenging separations problems.

References

1. Handbook of Isolation and Characterization of Impurities in Pharmaceuticals, S. Ahuja and K. Alsante Eds., Separation Science and Technology Series Vol. 5 (Academic Press, San Diego, CA 2003).

2. M. Bakshi and S. Singh, J. Pharm. Biomed. Anal. 28 (3) 1011–1040 (2002).

3. V. Kumar, H. Bhutani, and S. Singh, J. Pharm. Biomed. Anal. 43 (2) 769–73 (2007).

4. G. Guiochon and A. Tarafder, J. Chromatogr. A 1218 (8) 1037–1114 (2011).

5. K. Anton and C. Berger, Supercritical Fluid Chromatography with Packed Columns (Marcel Dekker, New York, 1998).

6. J.P. Kiplinger and P. M. Lefebvre, "Improving Productivity in Preparative Supercritical Fluid Chromatography Separations," presentation at the International Conference on Supercritical Fluid Chromatography (New York, 2011).

7. Scale-Up and Optimization in Preparative Chromatography: Principles and Biopharmaceutical Applications, A.S. Rathore and A. Velayudhan Eds., Chromatographic Science Series Vol. 88 (Marcel Dekker, New York, 2003).

Jeffrey P. Kiplinger* is president, Paul M. Lefebvre is director of laboratory operations, Michael J. Rego is a staff scientist, and John H. Tipping is a staff scientist, all at Averica Discovery Services Inc., One Innovation Drive, Three Biotech, Worcester MA 01605 USA.
.

* To whom all correspondance should be addressed.

Submitted: June 28, 2012. Accepted: Aug. 28, 2012.


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