Alternative Solvents for Extractables and Leachables Evaluation - Pharmaceutical Technology

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Alternative Solvents for Extractables and Leachables Evaluation
The authors examine alternative solvents for evaluation of process components that provide extraction equivalence and do not interfere chromatographically.


Pharmaceutical Technology
Volume 37, Issue 8, pp. 51-53

Conclusion
When comparing extraction efficiency between the various solvents for extractable screening studies, it is recommended that IPA be used as a worst-case solvent in cases for which surfactants are of interest. In addition, the ions from the mass spectra of compounds detected in the IPA extraction solvent can then be used to perform extracted ion analysis on the extracts that contain surfactants. Use of an alternate solvent such as IPA ensures that potential extractable compounds are not missed in the surfactant extractions during initial extractables screening.

Jennifer M. Roark, Mai N. Jacques, PhD, Erica J. Tullo, PhD, Andrew T. Blakinger, and Thomas C. Lehman*, PhD are all in the Method Development & Validation group at Eurofins Lancaster Laboratories, 2425 New Holland Pike, Lancaster, PA 17601, USA, 1.717.656.2300, http://www.lancasterlabspharm.com/.

*To whom all correspondence should be addressed.

References

1. FDA, Guidance for Industry: Container Closure Systems for Packaging Human Drugs and Biologics (Rockville, MD, May 1999).

2. CFR Title 21, Part 211.65 (Government Printing Office, Washington, DC, 2006).

3. Bio-Process Systems Alliance, Recommendations for Testing and Evaluation of Extractables from Single-Use Process Equipment, (Washington, DC, 2010).

4. Bio-Process Systems Alliance, BioProcess Intl. 5 (11) 36-49 (2007).

5. T. C. Lehman, "Evaluation of Model Solvents for Generating Extractable Compound Profiles from Single-Use Systems," presentation at AAPS Annual Meeting and Exposition (Washington DC, 2011).

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