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1

Identification and Quantitation Classifications for Extractables and Leachables

Journal:

PDA Journal of Pharmaceutical Science and Technology

Year:

2020

File:

PDF, 903 KB

2020

2

How One Might Experimentally Determine if Container Closure Systems and their Components and Materials of Construction Contribute Elemental Impurities to Packaged Pharmaceutical Drug Products

Journal:

PDA Journal of Pharmaceutical Science and Technology

Year:

2018

Language:

english

File:

PDF, 571 KB

english, 2018

3

Extractables and leachables considerations for prefilled syringes

Jenke, Dennis R

Journal:

Expert Opinion on Drug Delivery

Year:

2014

Language:

english

File:

PDF, 305 KB

english, 2014

4

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

Norwood, Daniel L., Jenke, Dennis, Manolescu, Cristina, Pennino, Scott, Grinberg, Nelu

Journal:

Journal of Liquid Chromatography & Related Technologies

Year:

2009

Language:

english

File:

PDF, 1.59 MB

english, 2009

5

Evaluation of the chemical compatibility of plastic contact materials and pharmaceutical products; safety considerations related to extractables and leachables

Journal:

Journal of Pharmaceutical Sciences

Year:

2007

Language:

english

File:

PDF, 272 KB

english, 2007

6

Identifying and Mitigating Errors in Screening for Organic Extractables and Leachables: Part 3: Considering Errors of Implementation and the Use of a Database to Judge and Promote Good Science and Efficient Practices

Journal:

PDA Journal of Pharmaceutical Science and Technology

Year:

2019

Language:

english

File:

PDF, 1.53 MB

english, 2019

7

Identifying and Mitigating Errors in Screening for Organic Extractables and Leachables: Part I; Introduction to Errors in Chromatographic Screening for Organic Extractables & Leachables and Discussion of the Error of Omission

Jenke, Dennis, Christiaens, Piet, Beusen, Jean-Marie, Verlinde, Phillipe, Baeten, Jan

Journal:

PDA Journal of Pharmaceutical Science and Technology

Year:

2019

Language:

english

File:

PDF, 1.90 MB

english, 2019

8

Materials in Manufacturing and Packaging Systems as Sources of Elemental Impurities in Packaged Drug Products: An Updated Literature Review

Journal:

PDA Journal of Pharmaceutical Science and Technology

Year:

2019

File:

PDF, 1.40 MB

2019

9

Chromatographic Method Validation: A Review of Current Practices and Procedures. I. General Concepts and Guidelines

Jenke, Dennis R.

Journal:

Journal of Liquid Chromatography & Related Technologies

Year:

1996

Language:

english

File:

PDF, 676 KB

english, 1996

10

The effect of solvent polarity on the accumulation of leachables from pharmaceutical product containers

Dennis Jenke, Alex Odufu, Mitchell Poss

Journal:

European Journal of Pharmaceutical Sciences

Year:

2006

Language:

english

File:

PDF, 381 KB

english, 2006

11

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

Jenke, Dennis R.

Journal:

Journal of Liquid Chromatography & Related Technologies

Year:

2004

Language:

english

File:

PDF, 227 KB

english, 2004

12

Organic Extractables from Packaging Materials: Chromatographic Methods Used for Identification and Quantification

Journal:

Journal of Liquid Chromatography & Related Technologies

Year:

2003

Language:

english

File:

PDF, 139 KB

english, 2003

13

Interactions between polymeric containers and their contained solution: Modeling of polymer-water solute partitioning via coupled solvent-water partition coefficients

Dennis R. Jenke, Richard A. Kenley, Denise S. Hayward

Journal:

Journal of Applied Polymer Science

Year:

1991

Language:

english

File:

PDF, 578 KB

english, 1991

14

Identification, Analysis and Safety Assessment of Leachables and Extractables

Journal:

TrAC Trends in Analytical Chemistry

Year:

2017

Language:

english

File:

PDF, 4.57 MB

english, 2017

15

Use of binary ethanol/water model solutions to mimic the interaction between a plastic material and pharmaceutical formulations

Dennis R. Jenke, Jill Brennan, Mark Doty, Mitchell Poss

Journal:

Journal of Applied Polymer Science

Year:

2003

Language:

english

File:

PDF, 113 KB

english, 2003

16

Extractables/leachables from plastic tubing used in product manufacturing

Dennis R. Jenke, James Story, Rukhsana Lalani

Journal:

International Journal of Pharmaceutics

Year:

2006

Language:

english

File:

PDF, 1.08 MB

english, 2006

17

Evaluation of various solvent systems for modeling solute sorption with plasticized polyvinyl chloride materials

Dennis R. Jenke

Journal:

Journal of Pharmaceutical Sciences

Year:

1993

Language:

english

File:

PDF, 502 KB

english, 1993

18

Chromatographic Method Validation: A Review of Current Practices and Procedures. Part II. Guidelines for Primary Validation Parameters†

Jenke, Dennis R.

Journal:

Instrumentation Science & Technology

Year:

1998

Language:

english

File:

PDF, 877 KB

english, 1998

19

Chromatographic Considerations in the Standardization of Liquid Chromatographic Methods Used for Extractables Screening

Jenke, Dennis, Liu, Norman

Journal:

Journal of Liquid Chromatography & Related Technologies

Year:

2016

Language:

english

File:

PDF, 561 KB

english, 2016

20

Model for estimating the accumulation of solutes leaching from polymeric containers into parenteral solutions

Dennis R. Jenke, Edward K. Chess, David C. Zietlow, Barrett E. Rabinow

Journal:

International Journal of Pharmaceutics

Year:

1992

Language:

english

File:

PDF, 542 KB

english, 1992

21

Modeling of solute sorption by polyvinyl chloride plastic infusion bags

Dennis R. Jenke

Journal:

Journal of Pharmaceutical Sciences

Year:

1993

Language:

english

File:

PDF, 635 KB

english, 1993

22

Quantitation of oxalate and citrate by ion chromatography with a buffered, strong acid eluent

Dennis R. Jenke

Journal:

Journal of Chromatography A

Year:

1988

Language:

english

File:

PDF, 451 KB

english, 1988

23

Chromatographic Method Validation: A Review of Current Practices and Procedures. III. Ruggedness, Re-Validation and System Suitability

Jenke, Dennis R.

Journal:

Journal of Liquid Chromatography & Related Technologies

Year:

1996

Language:

english

File:

PDF, 869 KB

english, 1996

24

Accumulation of extractables in buffer solutions from a polyolefin plastic container

Dennis R. Jenke, Jill M. Jene, Mitchell Poss, James Story, Tom Tsilipetros, Alex Odufu, William Terbush

Journal:

International Journal of Pharmaceutics

Year:

2005

Language:

english

File:

PDF, 683 KB

english, 2005

25

Interactions between polymer containers and parenteral solutions: Correlating equilibrium polymer-water interaction constants with solute partition coefficients

Denise S. Hayward, Dennis R. Jenke

Journal:

International Journal of Pharmaceutics

Year:

1990

Language:

english

File:

PDF, 669 KB

english, 1990

26

Drug Delivery via Ion Exchange Across a Fiber Membrane

Dennis R. Jenke

Journal:

Pharmaceutical Research

Year:

1989

File:

PDF, 491 KB

1989

27

Elimination of matrix related interferences in indirect photometric chromatography

Brown, David., Payton, Robert., Jenke, Dennis.

Journal:

Analytical Chemistry

Year:

1985

Language:

english

File:

PDF, 445 KB

english, 1985

28

Validation of a Liquid Chromatographic Method for Quantitation of Organic Compounds Leached from a Plastic Container into a Pharmaceutical Formulation

Jenke, Dennis, Jo Garber, Mary, Zietlow, David

Journal:

Journal of Liquid Chromatography & Related Technologies

Year:

2005

Language:

english

File:

PDF, 227 KB

english, 2005

29

The Chromatographic Efficiency of Several Commercially Available Ion Chromatography Columns

Jenke, Dennis R.

Journal:

Journal of Liquid Chromatography

Year:

1990

Language:

english

File:

PDF, 384 KB

english, 1990

30

Column poisoning by multivalent cations in ion chromatographic analysis for alkali metals

Dennis R. Jenke

Journal:

Journal of Chromatography A

Year:

1986

Language:

english

File:

PDF, 494 KB

english, 1986

31

Evaluation of assay specificity in non-suppressed ion chromatography

Lawrence A. Cruz, Dennis R. Jenke

Journal:

Journal of Chromatography A

Year:

1989

Language:

english

File:

PDF, 377 KB

english, 1989

32

Mathematical modeling of the extractables release from multi-layered plastic films used in drug product containers

Jenke, Dennis, Barge, Vishal J.

Journal:

Journal of Applied Polymer Science

Year:

2015

Language:

english

File:

PDF, 506 KB

english, 2015

33

Solute migration through polypropylene blend films

Dennis R. Jenke

Journal:

Journal of Applied Polymer Science

Year:

1992

Language:

english

File:

PDF, 582 KB

english, 1992

34

Prediction of Retention Characteristics of Multiprotic Anions in Ion Chromatography

Jenke, Dennis R.

Journal:

Analytical Chemistry

Year:

1994

Language:

english

File:

PDF, 1.50 MB

english, 1994

35

Media Regulation/Responsibility

Rubin, Bernard, Murray, John, Casebier, Allan, Casebier, Janet Jenks, Dennis, Everette E., Gillmor, Donald M., Grey, David L., Cole, Barry, Oettinger, Mal, Simmons, Steven J., Will, Thomas E.

Journal:

Communication Booknotes

Year:

1979

Language:

english

File:

PDF, 2.01 MB

english, 1979

36

Chemical changes in concentrated, acidic, metal-bearing wastewaters when treated with lime

Jenke, Dennis R., Pagenkopf, Gordon K., Diebold, Frank E.

Journal:

Environmental Science & Technology

Year:

1983

Language:

english

File:

PDF, 883 KB

english, 1983

37

[American Society of Agricultural and Biological Engineers ASABE/CSBE North Central Intersectional Meeting - ()] ASABE/CSBE North Central Intersectional Meeting - Oil and Biodiesel from Canola Having a High Content of Green Seed

Kristi Tostenson,, Dennis Wiesenborn,, Darrin Haagenson,, Vern Hofman,, Kent McKay,, Brian Jenks,, Scott Halley,

Year:

2006

File:

PDF, 232 KB

2006

38

Electroprecipitation treatment of acid mine wastewater

Dennis R. Jenke, Frank E. Diebold

Journal:

Year:

1984

Language:

english

File:

PDF, 385 KB

english, 1984

39

Modeling of analyte behavior in indirect photometric chromatography

Jenke, Dennis R.

Journal:

Analytical Chemistry

Year:

1984

Language:

english

File:

PDF, 817 KB

english, 1984

40

Controlled Extraction Studies Applied to Polyvinyl Chloride and Polyethylene Materials: Conclusions from the ELSIE Controlled Extraction Pilot Study

Teasdale, Andrew, Jahn, Michael, Bailey, Simon, Feilden, Andrew, Taylor, Graham, Corcoran, Marta L., Malick, Robert, Jenke, Dennis, Stults, Cheryl L. M., Nagao, Lee M.

Journal:

AAPS PharmSciTech

Year:

2015

Language:

english

File:

PDF, 561 KB

english, 2015

41

Effect of some operational variables on the efficiency of ion chromatographic separations

Dennis R. Jenke

Journal:

Journal of Chromatography A

Year:

1989

Language:

english

File:

PDF, 778 KB

english, 1989

42

Drug Delivery via Ion Exchange Across a Micromembrane

Dennis R. Jenke, Christopher D. Baron, Carol L. Mayers

Journal:

Pharmaceutical Research

Year:

1992

File:

PDF, 929 KB

1992

43

Computer simulation of an industrial wastewater treatment process

Dennis R. Jenke, Frank E. Diebold

Journal:

Year:

1985

Language:

english

File:

PDF, 474 KB

english, 1985

44

Determination of alkaline-earth metals in samples containing a large excess of alkali by ion chromatography

Journal:

Analytical Chemistry

Year:

1987

Language:

english

File:

PDF, 629 KB

english, 1987

45

Backtalk

Gaylord D. Morrison, Leo V. Loughead, Jr., Dennis O'Neill, Joelynn Snyder-Ott, Wilma C. Shafer, Ray H. Simpson, Frederick L. Jenks, George J. Michel, Jerry J. Vincent and William E. Roweton

Journal:

The Phi Delta Kappan

Year:

1973

Language:

english

File:

PDF, 971 KB

english, 1973

46

Use of multiple detectors and stepwise elution in ion chromatography without suppressor columns

Dennis R. Jenke, Presley K. Mitchell, Gordon K. Pagekopf

Journal:

Analytica Chimica Acta

Year:

1983

Language:

english

File:

PDF, 467 KB

english, 1983

47

Continued Development of Direct Aerosol Introduction in Constant Temperature Furnace Atomic Absorption Spectroscopy

Jenke, Dennis R., Woodriff, Ray

Journal:

Applied Spectroscopy

Year:

1983

Language:

english

File:

PDF, 345 KB

english, 1983

48

Recovery of valuable metals from acid mine drainage by selective titration

Dennis R. Jenke, Frank E. Diebold

Journal:

Year:

1983

Language:

english

File:

PDF, 438 KB

english, 1983

49

Comparison of Three Methods for the Extraction of Selected Anions from Media Used for the Collection of Airborne Particulates

Jenke, Dennis R.

Journal:

Journal of the Air Pollution Control Association

Year:

1983

Language:

english

File:

PDF, 665 KB

english, 1983

50

Utilization of extraction profiles to estimate the accumulation of extractables from polymeric materials

Dennis R. Jenke

Journal:

Journal of Applied Polymer Science

Year:

1997

Language:

english

File:

PDF, 114 KB

english, 1997

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