Leachables

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A Method Utilizing Ultra-High Performance Liquid Chromatography with Ultraviolet and Mass Spectrometric Detection for the Analysis of Material Extracts Produced during a Controlled Extraction Study
Steven A. Zdravkovic, Matthew D. Bruss, Robert F. Piccoli and Derek M. Wood

PDA Journal of Pharmaceutical Science and Technology September 2014, 68 (5) 504-526; DOI: https://doi.org/10.5731/pdajpst.2014.00992
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Perspectives on the PQRI Extractables and Leachables “Safety Thresholds and Best Practices” Recommendations for Inhalation Drug Products
Daniel L. Norwood, Lee M. Nagao and Cheryl L. M. Stults

PDA Journal of Pharmaceutical Science and Technology September 2013, 67 (5) 413-429; DOI: https://doi.org/10.5731/pdajpst.2013.00934
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The Product Quality Research Institute (PQRI) Leachables and Extractables Working Group Initiatives for Parenteral and Ophthalmic Drug Product (PODP)
Diane Paskiet, Dennis Jenke, Douglas Ball, Christopher Houston, Daniel L. Norwood and Ingrid Markovic

PDA Journal of Pharmaceutical Science and Technology September 2013, 67 (5) 430-447; DOI: https://doi.org/10.5731/pdajpst.2013.00936
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Extractables Characterization for Five Materials of Construction Representative of Packaging Systems Used for Parenteral and Ophthalmic Drug Products
Dennis Jenke, James Castner, Thomas Egert, Tom Feinberg, Alan Hendricker, Christopher Houston, Desmond G. Hunt, Michael Lynch, Arthur Shaw, Kumudini Nicholas, Daniel L. Norwood, Diane Paskiet, Michael Ruberto, Edward J. Smith and Frank Holcomb

PDA Journal of Pharmaceutical Science and Technology September 2013, 67 (5) 448-511; DOI: https://doi.org/10.5731/pdajpst.2013.00933
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Automated Solid Phase Extraction (SPE) LC/NMR Applied to the Structural Analysis of Extractable Compounds from a Pharmaceutical Packaging Material of Construction
Daniel L. Norwood, James O. Mullis, Mark Davis, Scott Pennino, Thomas Egert and Nina C. Gonnella

PDA Journal of Pharmaceutical Science and Technology May 2013, 67 (3) 267-287; DOI: https://doi.org/10.5731/pdajpst.2013.00920
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Identification of a Leachable Compound Detrimental to Cell Growth in Single-Use Bioprocess Containers
Matthew Hammond, Heather Nunn, Gary Rogers, Hans Lee, Anatolia-Liliana Marghitoiu, Lourdes Perez, Yasser Nashed-Samuel, Carl Anderson, Michael Vandiver and Sally Kline

PDA Journal of Pharmaceutical Science and Technology March 2013, 67 (2) 123-134; DOI: https://doi.org/10.5731/pdajpst.2013.00905

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Parenteral Drug Association, Inc.