Alternative Solvents for Extractables and Leachables Evaluation - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

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).

Join the discussion

What issues are you having with extractables and leachables evaluation?

Post your comments on http://www.pharmtech.com/linkedin


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