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Original Articles

Guidelines for the Design, Implementation, and Interpretation of Validations for Chromatographic Methods used to Quantitate Leachables/Extractables in Pharmaceutical Solutions

Pages 3141-3176 | Received 23 Jun 2004, Accepted 24 Jul 2004, Published online: 11 Jun 2009

Keep up to date with the latest research on this topic with citation updates for this article.

Read on this site (2)

DanielL. Norwood, Dennis Jenke, Cristina Manolescu, Scott Pennino & Nelu Grinberg. (2009) HPLC and LC/MS Analysis of Pharmaceutical Container Closure System Leachables and Extractables. Journal of Liquid Chromatography & Related Technologies 32:11-12, pages 1768-1827.
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Dennis Jenke, Mary Jo Garber & David Zietlow. (2005) Validation of a Liquid Chromatographic Method for Quantitation of Organic Compounds Leached from a Plastic Container into a Pharmaceutical Formulation. Journal of Liquid Chromatography & Related Technologies 28:2, pages 199-222.
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Articles from other publishers (5)

Luis Cuadros-Rodríguez, Marta Lazúen-Muros, Cristina Ruiz-Samblás & Natalia Navas-Iglesias. (2020) Leachables from plastic materials in contact with drugs. State of the art and review of current analytical approaches. International Journal of Pharmaceutics 583, pages 119332.
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Nicole Scherer, Klaudia Marcseková, Tobias Posset & Gerhard Winter. (2019) New studies on leachables in commercial scale protein drug filling lines using stir bar sorptive extraction coupled with TD-GC–MS and UPLC/QTOF-MS/MS analytics. International Journal of Pharmaceutics 555, pages 404-419.
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Cheryl L. M. Stults & Jason M. Creasey. 2012. Leachables and Extractables Handbook. Leachables and Extractables Handbook 449 506 .
Dennis Jenke. 2009. Compatibility of Pharmaceutical Products and Contact Materials. Compatibility of Pharmaceutical Products and Contact Materials 191 228 .
Dennis Jenke. (2007) Evaluation of the Chemical Compatibility of Plastic Contact Materials and Pharmaceutical Products; Safety Considerations Related to Extractables and Leachables. Journal of Pharmaceutical Sciences 96:10, pages 2566-2581.
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