Research ArticleTechnology/Application
Identifying and Mitigating Errors in Screening for Organic Extractables and Leachables: Part 1—Introduction to Errors in Chromatographic Screening for Organic Extractables and Leachables and Discussion of the Errors of Omission
Piet Christiaens, Jean-Marie Beusen, Philippe Verlinde, Jan Baeten and Dennis Jenke
PDA Journal of Pharmaceutical Science and Technology January 2020, 74 (1) 90-107; DOI: https://doi.org/10.5731/pdajpst.2018.009761
Piet Christiaens
1Nelson Labs, Romeinsestraat 12, 3001, Heverlee, Belgium
Jean-Marie Beusen
1Nelson Labs, Romeinsestraat 12, 3001, Heverlee, Belgium
Philippe Verlinde
1Nelson Labs, Romeinsestraat 12, 3001, Heverlee, Belgium
Jan Baeten
1Nelson Labs, Romeinsestraat 12, 3001, Heverlee, Belgium
Dennis Jenke
1Nelson Labs, Romeinsestraat 12, 3001, Heverlee, Belgium

References
- 1.↵U.S. Food and Drug Administration. Guidance for Industry: Container Closure Systems for Packaging Human Drugs and Biologics. Center for Biologics Evaluation and Research, U.S. Department of Health and Human Services: Rockville, MD, 1999.
- 2.↵European Medicines Agency. Guideline on Plastic Immediate Packaging Materials. EMA: London, 2005.
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- 5.↵U.S. Pharmacopeial Convention. General Chapter <1663> Assessment of Extractables Associated with Pharmaceutical Packaging/Delivery Systems. In USP 41–NF 36; USP: Rockville, MD, 2018; p 7910.
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- Mullis J. O.,
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- 10.↵Product Quality Research Institute Leachables and Extractables Working Group. Safety Thresholds and Best Practices for Extractables and Leachables in Orally Inhaled and Nasal Drug Products. PQRI: Arlington, VA, 2006.
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- Bull D. J.,
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- Jenke D.,
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In This Issue
PDA Journal of Pharmaceutical Science and Technology
Vol. 74, Issue 1
January/February 2020
Identifying and Mitigating Errors in Screening for Organic Extractables and Leachables: Part 1—Introduction to Errors in Chromatographic Screening for Organic Extractables and Leachables and Discussion of the Errors of Omission
Piet Christiaens, Jean-Marie Beusen, Philippe Verlinde, Jan Baeten, Dennis Jenke
PDA Journal of Pharmaceutical Science and Technology Jan 2020, 74 (1) 90-107; DOI: 10.5731/pdajpst.2018.009761
Identifying and Mitigating Errors in Screening for Organic Extractables and Leachables: Part 1—Introduction to Errors in Chromatographic Screening for Organic Extractables and Leachables and Discussion of the Errors of Omission
Piet Christiaens, Jean-Marie Beusen, Philippe Verlinde, Jan Baeten, Dennis Jenke
PDA Journal of Pharmaceutical Science and Technology Jan 2020, 74 (1) 90-107; DOI: 10.5731/pdajpst.2018.009761
Jump to section
- Article
- Abstract
- Introduction
- Analytics of Organic Extractables and Leachables
- Limitations of the Chromatographic Screening Process
- Addressing the Limitations via an Internal Extractables and Leachables Database
- An Example of an Internal Extractables and Leachables Database
- Errors of Omission, a Fatal Error
- Concluding Thoughts
- Conflict of Interest Declaration
- References
- Figures & Data
- References
- Info & Metrics
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- Identifying and Mitigating Errors in Screening for Organic Extractables and Leachables: Part 2--Errors of Inexact Identification and Inaccurate Quantitation
- Identifying and Mitigating Errors in Screening for Organic Extractables and Leachables: Part 3--Considering Errors of Implementation and the Use of a Database to Judge and Promote Good Science and Efficient Practices