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There are 13871 results for: content related to: Determination of Extractables and Leachables from Single-Use Systems

  1. Analytical Leachables Studies

    Leachables and Extractables Handbook: Safety Evaluation, Qualification, and Best Practices Applied to Inhalation Drug Products

    Andrew D. Feilden, Andy Rignall, Pages: 417–447, 2012

    Published Online : 28 FEB 2012, DOI: 10.1002/9781118147672.ch17

  2. On developing a process for conducting extractable–leachable assessment of components used for storage of biopharmaceuticals

    Journal of Pharmaceutical Sciences

    Volume 99, Issue 5, May 2010, Pages: 2209–2218, Aditya A. Wakankar, Y. John Wang, Eleanor Canova-Davis, Stacey Ma, Dieter Schmalzing, Josh Grieco, Terry Milby, Theresa Reynolds, Kellen Mazzarella, Ed Hoff, Stephen Gomez and Sherry Martin-Moe

    Version of Record online : 28 DEC 2009, DOI: 10.1002/jps.22012

  3. Analytical Best Practices for the Evaluation and Management of Extractables and Leachables in Orally Inhaled and Nasal Drug Products

    Leachables and Extractables Handbook: Safety Evaluation, Qualification, and Best Practices Applied to Inhalation Drug Products

    Daniel L. Norwood, Cheryl L. M. Stults, Lee M. Nagao, Pages: 153–183, 2012

    Published Online : 28 FEB 2012, DOI: 10.1002/9781118147672.ch10

  4. Focus on Emerging Concepts

    Compatibility of Pharmaceutical Products and Contact Materials: Safety Considerations Associated with Extractables and Leachables

    Dennis Jenke, Pages: 319–346, 2008

    Published Online : 1 OCT 2008, DOI: 10.1002/9780470459416.ch12

  5. Analytical Techniques for Identification and Quantitation of Extractables and Leachables

    Leachables and Extractables Handbook: Safety Evaluation, Qualification, and Best Practices Applied to Inhalation Drug Products

    Daniel L. Norwood, Thomas N. Feinberg, James O. Mullis, Scott J. Pennino, Pages: 241–287, 2012

    Published Online : 28 FEB 2012, DOI: 10.1002/9781118147672.ch13

  6. Pharmaceutical Container Closure Systems: Selection and Qualification of Materials

    Leachables and Extractables Handbook: Safety Evaluation, Qualification, and Best Practices Applied to Inhalation Drug Products

    Douglas J. Ball, William P. Beierschmitt, Arthur J. Shaw, Pages: 217–240, 2012

    Published Online : 28 FEB 2012, DOI: 10.1002/9781118147672.ch12

  7. Overview of Leachables and Extractables in Orally Inhaled and Nasal Drug Products

    Leachables and Extractables Handbook: Safety Evaluation, Qualification, and Best Practices Applied to Inhalation Drug Products

    Douglas J. Ball, Daniel L. Norwood, Lee M. Nagao, Pages: 1–19, 2012

    Published Online : 28 FEB 2012, DOI: 10.1002/9781118147672.ch1

  8. Material Screening and Characterization

    Compatibility of Pharmaceutical Products and Contact Materials: Safety Considerations Associated with Extractables and Leachables

    Dennis Jenke, Pages: 89–156, 2008

    Published Online : 1 OCT 2008, DOI: 10.1002/9780470459416.ch4

  9. Nomenclature and General Concepts

    Compatibility of Pharmaceutical Products and Contact Materials: Safety Considerations Associated with Extractables and Leachables

    Dennis Jenke, Pages: 27–75, 2008

    Published Online : 1 OCT 2008, DOI: 10.1002/9780470459416.ch2

  10. Safety Thresholds in the Pharmaceutical Development Process for OINDP: An Industry Perspective

    Leachables and Extractables Handbook: Safety Evaluation, Qualification, and Best Practices Applied to Inhalation Drug Products

    David Alexander, James Blanchard, Pages: 79–92, 2012

    Published Online : 28 FEB 2012, DOI: 10.1002/9781118147672.ch6

  11. The Analytical Evaluation Threshold (AET) and its Relationship to Safety Thresholds

    Leachables and Extractables Handbook: Safety Evaluation, Qualification, and Best Practices Applied to Inhalation Drug Products

    Daniel L. Norwood, James O. Mullis, Scott J. Pennino, Pages: 59–78, 2012

    Published Online : 28 FEB 2012, DOI: 10.1002/9781118147672.ch5

  12. Product Maintenance

    Compatibility of Pharmaceutical Products and Contact Materials: Safety Considerations Associated with Extractables and Leachables

    Dennis Jenke, Pages: 271–313, 2008

    Published Online : 1 OCT 2008, DOI: 10.1002/9780470459416.ch10

  13. Extractables: The Controlled Extraction Study

    Leachables and Extractables Handbook: Safety Evaluation, Qualification, and Best Practices Applied to Inhalation Drug Products

    Thomas N. Feinberg, Daniel L. Norwood, Alice T. Granger, Dennis Jenke, Pages: 289–329, 2012

    Published Online : 28 FEB 2012, DOI: 10.1002/9781118147672.ch14

  14. Impact of Residual Impurities and Contaminants on Protein Stability

    Journal of Pharmaceutical Sciences

    Volume 103, Issue 5, May 2014, Pages: 1315–1330, Wei Wang, Arun Alphonse Ignatius and Santosh V. Thakkar

    Version of Record online : 12 MAR 2014, DOI: 10.1002/jps.23931

  15. Introduction

    Compatibility of Pharmaceutical Products and Contact Materials: Safety Considerations Associated with Extractables and Leachables

    Dennis Jenke, Pages: 1–26, 2008

    Published Online : 1 OCT 2008, DOI: 10.1002/9780470459416.ch1

  16. The Prototype Stage

    Compatibility of Pharmaceutical Products and Contact Materials: Safety Considerations Associated with Extractables and Leachables

    Dennis Jenke, Pages: 157–190, 2008

    Published Online : 1 OCT 2008, DOI: 10.1002/9780470459416.ch5

  17. Extractables: Case Study of a Sulfur-Cured Elastomer

    Leachables and Extractables Handbook: Safety Evaluation, Qualification, and Best Practices Applied to Inhalation Drug Products

    Daniel L. Norwood, Fenghe Qiu, James R. Coleman, James O. Mullis, Alice T. Granger, Keith McKellop, Michelle Raikes, John A. Robson, Pages: 331–386, 2012

    Published Online : 28 FEB 2012, DOI: 10.1002/9781118147672.ch15

  18. The Application of the Safety Thresholds to Qualify Leachables from Plastic Container Closure Systems Intended for Pharmaceutical Products: A Regulatory Perspective

    Leachables and Extractables Handbook: Safety Evaluation, Qualification, and Best Practices Applied to Inhalation Drug Products

    Douglas J. Ball, Daniel L. Norwood, Cheryl L. M. Stults, Lee M. Nagao, Pages: 129–152, 2012

    Published Online : 28 FEB 2012, DOI: 10.1002/9781118147672.ch9

  19. The Chemistry and Toxicology Partnership: Extractables and Leachables Information Sharing Among the Chemists and Toxicologists

    Leachables and Extractables Handbook: Safety Evaluation, Qualification, and Best Practices Applied to Inhalation Drug Products

    Cheryl L. M. Stults, Ronald Wolff, Douglas J. Ball, Pages: 93–115, 2012

    Published Online : 28 FEB 2012, DOI: 10.1002/9781118147672.ch7

  20. The Early Development Stage

    Compatibility of Pharmaceutical Products and Contact Materials: Safety Considerations Associated with Extractables and Leachables

    Dennis Jenke, Pages: 191–228, 2008

    Published Online : 1 OCT 2008, DOI: 10.1002/9780470459416.ch6