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Original Articles

HPLC and LC/MS Analysis of Pharmaceutical Container Closure System Leachables and Extractables

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Pages 1768-1827 | Published online: 19 May 2009

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Kashyap Thummar, Rinkal Vasoya, Bindiya Dama, Harsh Ladolkar, Mihir Raval & Navin Sheth. (2020) Determination of Extractable and Leachable Phthalates from Pharmaceutical Packaging by LC-MS/MS. Analytical Chemistry Letters 10:1, pages 93-103.
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Dennis Jenke & Norman Liu. (2016) Chromatographic considerations in the standardization of liquid chromatographic methods used for extractables screening. Journal of Liquid Chromatography & Related Technologies 39:13, pages 613-619.
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Wei Wei, Huiting Huang, Jing Cui & Zhenggui Wei. (2014) EVALUATION OF AMORPHOUS CALCIUM PHOSPHATE AS AN ADVANTAGEOUS SOLID-PHASE EXTRACTION ADSORBENT FOR ANALYSIS OF OXALIC ACID IN PLANT XYLEM SAPS BY RP-HPLC. Journal of Liquid Chromatography & Related Technologies 37:18, pages 2667-2680.
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Andrei Medvedovici, Florin Albu & Victor David. (2010) HANDLING DRAWBACKS OF MASS SPECTROMETRIC DETECTION COUPLED TO LIQUID CHROMATOGRAPHY IN BIOANALYSIS. Journal of Liquid Chromatography & Related Technologies 33:9-12, pages 1255-1286.
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Articles from other publishers (24)

Nitish Sharma, Yashada Brahmankar, Diksha Babar, Tejas Bhogle, Ramdas Mirase, Rajeshwari Rathod & Ravi Shah. (2023) Systematic Approaches on Extractable and Leachable Study Designs in Pharmaceuticals and Medical Devices: A Review. Journal of Packaging Technology and Research.
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Yangguo Xie, Lei Zhang, Wei Hou, Ying Cheng, Feifei Luo, Zhuoyu Liu & Zhongli Zhang. (2023) A Novel Method for Monitoring N-Nitrosamines Impurities Using NH2-MIL-101(Fe) Mediated Dispersive Micro-Solid Phase Extraction Coupled with LC-MS/MS in Biopharmaceuticals. Journal of Pharmaceutical Sciences.
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Marie R.G. Kopp, Fulvio Grigolato, Dominik Zürcher, Tapan K. Das, Danny Chou, Klaus Wuchner & Paolo Arosio. (2023) Surface-Induced Protein Aggregation and Particle Formation in Biologics: Current Understanding of Mechanisms, Detection and Mitigation Strategies. Journal of Pharmaceutical Sciences 112:2, pages 377-385.
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Feifei Luo, Yunya Liu, Yangguo Xie, Wei Hou, Lei Zhang & Zhongli Zhang. (2022) Simultaneous determination of 13 nitrosamine impurities in biological medicines using salting-out liquid-liquid extraction coupled with liquid chromatography tandem mass spectrometry. Journal of Pharmaceutical and Biomedical Analysis 218, pages 114867.
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Dennis Jenke. 2022. Extractables and Leachables. Extractables and Leachables 73 146 .
Jianwei Li. (2022) Evaluation of Retention Range of Extractables Under Linear Gradient Conditions for Reversed-Phase Chromatographic Considerations and Requirements in Extractables Analytical Methods for Chemical Characterization of Medical Devices. Chromatographia 85:8, pages 755-771.
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Eric M. Sussman, Berk Oktem, Irada S. Isayeva, Jinrong Liu, Samanthi Wickramasekara, Vaishnavi Chandrasekar, Keaton Nahan, Hainsworth Y. Shin & Jiwen Zheng. (2022) Chemical Characterization and Non-targeted Analysis of Medical Device Extracts: A Review of Current Approaches, Gaps, and Emerging Practices. ACS Biomaterials Science & Engineering 8:3, pages 939-963.
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James H. Bridson, Evamaria C. Gaugler, Dawn A. Smith, Grant L. Northcott & Sally Gaw. (2021) Leaching and extraction of additives from plastic pollution to inform environmental risk: A multidisciplinary review of analytical approaches. Journal of Hazardous Materials 414, pages 125571.
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Moolchand Kurmi, Shishir Prasad, Narayana Swamy Panduranga, Karthik Jayaraman & Hemant Bhutani. (2020) Identification of extractables by liquid chromatography-high resolution mass spectrometry: A case study to understand the extraction profile of different disposable syringes. Journal of Pharmaceutical and Biomedical Analysis 191, pages 113602.
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Yana Znamenskaya Falk, Anna Runnsjö, Anthony Pettigrew, Dieter Scherer, Johan Engblom & Vitaly Kocherbitov. (2020) Interactions of Perfluorohexyloctane With Polyethylene and Polypropylene Pharmaceutical Packaging Materials. Journal of Pharmaceutical Sciences 109:7, pages 2180-2188.
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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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Xuechun Sun, Xuebin Xing & Zhenxia Du. (2020) Application of dispersive liquid–liquid microextraction based on solidification of floating organic drop for the determination of extractables from pharmaceutical packaging materials. Talanta 209, pages 120540.
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Vincent P. Sica, Kady L. Krivos, Douglas E. Kiehl, Christopher J. Pulliam, Ian D. Henry & Timothy R. Baker. (2019) The role of mass spectrometry and related techniques in the analysis of extractable and leachable chemicals. Mass Spectrometry Reviews 39:1-2, pages 212-226.
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Joel D. Rindelaub, Zane Baird, Bruce A. Lindner & Angela A. Strantz. (2019) Identifying extractable profiles from 3D printed medical devices. PLOS ONE 14:5, pages e0217137.
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Camille Fauchere, Markoulina Berger-Gryllaki & Farshid Sadeghipour. (2019) Investigation of Drug-Packaging Interactions with Mass Spectroscopy Detectors: A Meta-Synthesis of the Literature. Pharmaceutical Technology in Hospital Pharmacy 4:1, pages 3-14.
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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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Pauline Legrand, Anne Desdion, Gaétan Boccadifuoco, Amélie Dufaÿ Wojcicki, Alan Worsley, Vincent Boudy & Sophie Goulay Dufay. (2018) Development of an HPLC/UV method for the evaluation of extractables and leachables in plastic: Application to a plastic-packaged calcium gluconate glucoheptonate solution. Journal of Pharmaceutical and Biomedical Analysis 155, pages 298-305.
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Dennis Jenke. (2018) Identification, analysis and safety assessment of leachables and extractables. TrAC Trends in Analytical Chemistry 101, pages 56-65.
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Steven A. Zdravkovic, Cindy T. Duong, Ashley A. Hellenbrand, Steven R. Duff & Alyssa L. Dreger. (2018) Establishment of a reference standard database for use in the qualitative and semi-quantitative analysis of pharmaceutical contact materials within an extractables survey by GC–MS. Journal of Pharmaceutical and Biomedical Analysis 151, pages 49-60.
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Xianghui Li, Lu Qiu, Yueyue Li, Xiaofei Chen, Zhenyu Zhu & Yifeng Chai. (2015) Assessment of the hemolysis and endothelial cell cytotoxicity induced by residual linear alkylbenzene sulfonates on pharmaceutical rubber stoppers based on HPLC-ESI-MS. Biomedical Chromatography 29:9, pages 1350-1355.
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I. Vardakou, S. Karampela, I. Papoutsis, Ch. Spiliopoulou, S. Athanaselis & C. Pistos. (2014) Migration study of zinc dibutyldithiocarbamate in eye drops solutions. Journal of Analytical Chemistry 69:11, pages 1096-1101.
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Denise Bohrer. 2012. Sources of Contamination in Medicinal Products and Medical Devices. Sources of Contamination in Medicinal Products and Medical Devices 185 227 .
Daniel L. Norwood, Thomas N. Feinberg, James O. Mullis & Scott J. Pennino. 2012. Leachables and Extractables Handbook. Leachables and Extractables Handbook 241 287 .
. (2009) Current literature in mass spectrometry. Journal of Mass Spectrometry 44:10, pages 1542-1553.
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