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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

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

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

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

11

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

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

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

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

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

17

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

18

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

19

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

20

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

21

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

22

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

23

Identification of caprolactam oligomers and related compounds in aqueous extracts of nylon-6

Dennis Jenke, Mitchell Poss, Salma Sadain, James Story, Walter Smith, Duane Reiber

Journal:

Journal of Applied Polymer Science

Year:

2005

Language:

english

File:

PDF, 132 KB

english, 2005

24

Examination of data relating to the thermodynamic and kinetic interactions between nonvolatile aqueous solutes and three ethylene–vinyl acetate copolymers

Dennis R. Jenke

Journal:

Journal of Applied Polymer Science

Year:

2006

Language:

english

File:

PDF, 103 KB

english, 2006

25

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

26

Determination of solute-polymer interaction constants via chromatography with polymer capillaries

Dennis R. Jenke

Journal:

Journal of Chromatography A

Year:

1992

Language:

english

File:

PDF, 749 KB

english, 1992

27

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

28

Quantitation of sodium hydrogensulfite in parenteral samples by a flow-injection method

Dennis R. Jenke

Journal:

Analytica Chimica Acta

Year:

1989

Language:

english

File:

PDF, 321 KB

english, 1989

29

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

30

Determination of trace levels of oxytocin in pharmaceutical solutions by high-performance liquid chromatography

David S. Brown, Dennis R. Jenke

Journal:

Journal of Chromatography A

Year:

1987

Language:

english

File:

PDF, 811 KB

english, 1987

31

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

32

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

33

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

34

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

35

Modeling of analyte response to changing eluent composition in suppressed ion chromatography

Dennis R. Jenke, Gordon K. Pagenkopf

Journal:

Journal of Chromatography A

Year:

1983

Language:

english

File:

PDF, 312 KB

english, 1983

36

Determination of alcohols in pharmaceuticals by ion-exclusion chromatography

Geriann Iwinski, Dennis R. Jenke

Journal:

Journal of Chromatography A

Year:

1987

Language:

english

File:

PDF, 459 KB

english, 1987

37

Evaluation of model solvent systems for assessing the accumulation of container extractables in drug formulations

Journal:

International Journal of Pharmaceutics

Year:

2001

Language:

english

File:

PDF, 167 KB

english, 2001

38

Shoot organogenesis from petiole explants in the aquatic plantNymphoides indica

Matthew A. Jenks, Michael E. Kane, Dennis B. McConnell

Journal:

Plant Cell, Tissue and Organ Culture

Year:

2000

Language:

english

File:

PDF, 493 KB

english, 2000

39

Effect of Solution Phase Composition on the Interaction Between Aqueous Model Solutes and Polymeric Container Materials

Dennis R. Jenke

Journal:

Pharmaceutical Research

Year:

1991

File:

PDF, 801 KB

1991

40

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

41

Influence of Solute Degradation on the Accumulation of Solutes Migrating into Solution from Polymeric Parenteral Containers

Lawrence A. Cruz, Mai P. Jenke, Richard A. Kenley, Ming J. Chen, Dennis R. Jenke

Journal:

Pharmaceutical Research

Year:

1990

File:

PDF, 898 KB

1990

42

Determination of Solute–Polymer Interaction Properties and Their Application to Parenteral Product Container Compatibility Evaluations

Richard A. Kenley, Dennis R. Jenke

Journal:

Pharmaceutical Research

Year:

1990

File:

PDF, 1.19 MB

1990

43

Drug Binding by Reservoirs in Elastomeric Infusion Devices

Dennis R. Jenke

Journal:

Pharmaceutical Research

Year:

1994

File:

PDF, 790 KB

1994

44

Determination of Solute–Polymer Interaction Properties via Two-Stage Extraction

Dennis R. Jenke

Journal:

Pharmaceutical Research

Year:

1994

File:

PDF, 329 KB

1994

45

Stabilization of Oxygen-Sensitive Formulations via a Secondary Oxygen Scavenger

Carol L. Mayers, Dennis R. Jenke

Journal:

Pharmaceutical Research

Year:

1993

File:

PDF, 645 KB

1993

46

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

47

Modeling of the leachables impact on the engineering of parenteral product container systems

Dennis R. Jenke, Edward K. Chess, George Jakubowski

Journal:

International Journal of Pharmaceutics

Year:

1994

Language:

english

File:

PDF, 648 KB

english, 1994

48

Drug Delivery via Ion Exchange Across a Fiber Membrane

Dennis R. Jenke

Journal:

Pharmaceutical Research

Year:

1989

File:

PDF, 491 KB

1989

49

Simultaneous Emission/Absorption Analysis in Constant Temperature Furnace Atomic Spectroscopy

Jenke, Dennis R., Woodriff, Ray

Journal:

Applied Spectroscopy

Year:

1982

Language:

english

File:

PDF, 331 KB

english, 1982

50

Direct Aerosol Introduction in Constant-temperature Furnace Atomic Absorption Spectroscopy

Jenke, Dennis R., Woodriff, Ray

Journal:

Applied Spectroscopy

Year:

1982

Language:

english

File:

PDF, 539 KB

english, 1982

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