Leachables and Extractables Handbook
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27

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Published By John Wiley & Sons, Inc.

9781118147672, 9780470173657

Latest Documents Most Cited Documents Contributed Authors Related Sources Related Keywords

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 ◽

10.1002/9781118147672.ch9 ◽

2012 ◽

pp. 129-152

Author(s):

Kumudini Nicholas

Keyword(s):

Pharmaceutical Products ◽

Plastic Container ◽

Closure Systems ◽

Regulatory Perspective ◽

Container Closure

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Index

Leachables and Extractables Handbook ◽

10.1002/9781118147672.index ◽

2012 ◽

pp. 669-683

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Appendix 1: Experimental Protocol for Controlled Extraction Studies on Elastomeric Test Articles

Leachables and Extractables Handbook ◽

10.1002/9781118147672.app1 ◽

2012 ◽

pp. 617-629

Keyword(s):

Experimental Protocol

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A General Overview of the Suitability for Intended Use Requirements for Materials Used in Pharmaceutical Systems

Leachables and Extractables Handbook ◽

10.1002/9781118147672.ch2 ◽

2012 ◽

pp. 21-36 ◽

Cited By ~ 1

Author(s):

Dennis Jenke

Keyword(s):

General Overview ◽

Materials Used ◽

Intended Use

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Use of Safety Thresholds in the Pharmaceutical Development Process for OINDP: U.S. Regulatory Perspectives

Leachables and Extractables Handbook ◽

10.1002/9781118147672.ch8 ◽

2012 ◽

pp. 117-127

Author(s):

Timothy J. McGovern

Keyword(s):

Development Process ◽

Pharmaceutical Development

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Critical Component Quality Control and Specification Strategies

Leachables and Extractables Handbook ◽

10.1002/9781118147672.ch19 ◽

2012 ◽

pp. 507-548

Author(s):

Terrence Tougas ◽

Suzette Roan ◽

Barbara Falco

Keyword(s):

Quality Control ◽

Critical Component ◽

Component Quality

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Pharmaceutical Container Closure Systems: Selection and Qualification of Materials

Leachables and Extractables Handbook ◽

10.1002/9781118147672.ch12 ◽

2012 ◽

pp. 217-240 ◽

Cited By ~ 2

Author(s):

Douglas J. Ball ◽

William P. Beierschmitt ◽

Arthur J. Shaw

Keyword(s):

Closure Systems ◽

Container Closure

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Chemical and Physical Attributes of Plastics and Elastomers: Impact on the Extractables Profile of Container Closure Systems

Leachables and Extractables Handbook ◽

10.1002/9781118147672.ch11 ◽

2012 ◽

pp. 185-215

Author(s):

Michael A. Ruberto ◽

Diane Paskiet ◽

Kimberly Miller

Keyword(s):

Closure Systems ◽

Physical Attributes ◽

Container Closure

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Analytical Leachables Studies

Leachables and Extractables Handbook ◽

10.1002/9781118147672.ch17 ◽

2012 ◽

pp. 417-447

Author(s):

Andrew D. Feilden ◽

Andy Rignall

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

Leachables and Extractables Handbook ◽

10.1002/9781118147672.ch7 ◽

2012 ◽

pp. 93-115

Author(s):

Cheryl L. M. Stults ◽

Ronald Wolff ◽

Douglas J. Ball

Keyword(s):

Information Sharing

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